Glenda Pearson provides her contact information and experience as a Clinical Research Associate. She has over 20 years of experience as a registered nurse and clinical research coordinator. Her roles have included clinical site management, establishing relationships with sponsors and vendors, ensuring compliance with regulations, and educating patients. She believes in the ability of research to cure disease and has extensive knowledge of clinical trials and good clinical practice guidelines.
Garret Cook completed a 36-hour clinical rotation in the emergency department of an acute care hospital as part of a nurse refresher program. He demonstrated competence in various nursing skills including vital sign monitoring, wound care, medication administration, and use of an electronic medical record system. The charge nurse and other nurses praised Garret for his medical knowledge, hard work, and excellent teamwork. He was described as an active learner who will be an asset to any healthcare facility.
An audit was conducted of a Patient Group Direction (PGD) implemented at a hospital to provide pre-operative Staphylococcus aureus decolonization treatment to elective spinal surgery patients. The PGD involved patients using chlorhexidine wash, mupirocin ointment, and mouthwash. Over 7 months, 56.8% of 791 spinal surgery patients received the PGD. Reasons for not receiving it included no pre-operative assessment or private insurance. Staff reported smooth implementation and patient surveys found most understood and followed the PGD. Surgical site infection rates in spinal patients decreased compared to the previous year, though the full impact was unclear due to lag times. Continued monitoring was recommended to further
The Deteriorating Patient and National Early Warning Score (NEWS) programme, marks the two year anniversary of the launch of the West of England Patient Safety Collaborative. These slides focus on celebrating our impact and demonstrable results across the region.
Webinar Series on COVID-19: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research, NIH
Speaker: Dr. Tan Hui Siu, Paediatrician subspecialized in Bioethics from Ampang Hospital, MOH Malaysia.
More info about the speaker and this webinar available here: https://clinupcovid.mailerpage.com/resources/j7t5n5-dnr-and-ethics-in-covid-19-era
This document outlines plans for at-home COVID-19 testing and treatment. It proposes training local doctors to provide: effective home triage, COVID-19 serum testing, patient education, and initiation of empiric treatment protocols. Treatments may include IV therapies, antibiotics, supplements, and potential stem cell therapies. The objective is to identify local providers to offer home outreach, triage and isolation care under their guidance and protocols. An at-home visit protocol is described involving screening, testing, telemedicine consultation and establishing a treatment plan. Potential treatment options discussed include IV vitamins, antibiotics, supplements and investigational stem cell therapies. The document introduces the team involved including physicians with expertise in functional medicine, cosmetic surgery and naturo
Webinar Series on Demystifying Phases in Clinical Trials & COVID-19 Updates organized by Institute for Clinical Research (ICR), NIH
Speaker: Dr. Richard Lim Boon Leong is a Consultant Palliative Medicine Physician and Head of Palliative Care Unit, Selayang Hospital, Malaysia
More information, please visit: https://clinupcovid.mailerpage.com/resources/w5b4h7-palliative-care-in-covid-19-malay
How To Safely Implement A Fast Track Programensteve
The document discusses how to safely implement a fast track recovery program in a hospital. It outlines key steps such as getting agreement from different hospital disciplines on evidence-based fast track interventions, educating staff, regularly reviewing implementation, and measuring outcomes like length of stay, readmission rates, and patient/staff satisfaction. It also discusses prehabilitation, perioperative fluid management, and creating an optimal postoperative ward environment to enhance recovery.
Garret Cook completed a 36-hour clinical rotation in the emergency department of an acute care hospital as part of a nurse refresher program. He demonstrated competence in various nursing skills including vital sign monitoring, wound care, medication administration, and use of an electronic medical record system. The charge nurse and other nurses praised Garret for his medical knowledge, hard work, and excellent teamwork. He was described as an active learner who will be an asset to any healthcare facility.
An audit was conducted of a Patient Group Direction (PGD) implemented at a hospital to provide pre-operative Staphylococcus aureus decolonization treatment to elective spinal surgery patients. The PGD involved patients using chlorhexidine wash, mupirocin ointment, and mouthwash. Over 7 months, 56.8% of 791 spinal surgery patients received the PGD. Reasons for not receiving it included no pre-operative assessment or private insurance. Staff reported smooth implementation and patient surveys found most understood and followed the PGD. Surgical site infection rates in spinal patients decreased compared to the previous year, though the full impact was unclear due to lag times. Continued monitoring was recommended to further
The Deteriorating Patient and National Early Warning Score (NEWS) programme, marks the two year anniversary of the launch of the West of England Patient Safety Collaborative. These slides focus on celebrating our impact and demonstrable results across the region.
Webinar Series on COVID-19: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research, NIH
Speaker: Dr. Tan Hui Siu, Paediatrician subspecialized in Bioethics from Ampang Hospital, MOH Malaysia.
More info about the speaker and this webinar available here: https://clinupcovid.mailerpage.com/resources/j7t5n5-dnr-and-ethics-in-covid-19-era
This document outlines plans for at-home COVID-19 testing and treatment. It proposes training local doctors to provide: effective home triage, COVID-19 serum testing, patient education, and initiation of empiric treatment protocols. Treatments may include IV therapies, antibiotics, supplements, and potential stem cell therapies. The objective is to identify local providers to offer home outreach, triage and isolation care under their guidance and protocols. An at-home visit protocol is described involving screening, testing, telemedicine consultation and establishing a treatment plan. Potential treatment options discussed include IV vitamins, antibiotics, supplements and investigational stem cell therapies. The document introduces the team involved including physicians with expertise in functional medicine, cosmetic surgery and naturo
Webinar Series on Demystifying Phases in Clinical Trials & COVID-19 Updates organized by Institute for Clinical Research (ICR), NIH
Speaker: Dr. Richard Lim Boon Leong is a Consultant Palliative Medicine Physician and Head of Palliative Care Unit, Selayang Hospital, Malaysia
More information, please visit: https://clinupcovid.mailerpage.com/resources/w5b4h7-palliative-care-in-covid-19-malay
How To Safely Implement A Fast Track Programensteve
The document discusses how to safely implement a fast track recovery program in a hospital. It outlines key steps such as getting agreement from different hospital disciplines on evidence-based fast track interventions, educating staff, regularly reviewing implementation, and measuring outcomes like length of stay, readmission rates, and patient/staff satisfaction. It also discusses prehabilitation, perioperative fluid management, and creating an optimal postoperative ward environment to enhance recovery.
Vince & Associates Clinical Research has been providing clinical research services for 15 years. They have an experienced team focusing on quality research data while also prioritizing speed, responsiveness, and accountability for clients. They operate using the Physician Research Model where studies are led by principal investigators involved in all aspects of trials. This approach and their expertise in special populations has led to long-term contracts with the FDA and NIDA.
Webinar Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH
Speaker: Dr. Soo Kok Foong, Emergency Medicine Physician in Sungai Buloh Hospital, Ministry of Health Malaysia.
The document discusses the Early Warning Score (EWS) system, which is a simple scoring method used to rapidly identify clinically deteriorating patients based on 5 physiological parameters. Studies have shown that implementing an EWS protocol can effectively reduce mortality and morbidity for deteriorating patients as well as prevent ICU admissions. The EWS allows for early detection of patients who need urgent medical review and intervention to avoid further physiological deterioration.
Lakeland Regional Health initiated a multi-phase process improvement effort in October 2013 to reduce surgical site infections across their preoperative, intraoperative, and postoperative phases of care. Standardized protocols were implemented, including use of chlorhexidine for skin preparation, standardized antibiotic administration, and monitoring of operating room conditions. This led to a reduction in their surgical site infection rate compared to previous years. The project demonstrated that implementing evidence-based standards can successfully decrease surgical site infections across a large health system.
Patient safety and error reduction approachesLallu Joseph
This document discusses approaches to reducing medical errors and improving patient safety. It begins by defining patient safety and outlining the prevalence of medical errors. It then provides an example of a wrong patient surgery that occurred due to lack of patient identification and unfollowed protocols. The document advocates for a systems approach to error reduction rather than individual discipline. It promotes techniques from human factor engineering like failure mode and effects analysis. Overall, the document argues that senior leadership must support efforts to standardize tasks, reduce handoffs, track performance, and redesign systems to more reliably prevent harm to patients.
- The study compared ocrelizumab (OCR) to placebo in treating primary progressive multiple sclerosis (PPMS) over approximately 3 years. Baseline characteristics were balanced between the treatment groups.
- OCR met the primary endpoint of reducing disability progression confirmed at 12 weeks compared to placebo. Key secondary endpoints including disability progression at 24 weeks, timed walking test, brain lesion volume, and brain volume loss were also significantly improved by OCR compared to placebo.
- Adverse events including infections were more common with OCR, but serious adverse events and discontinuation due to adverse events were similar between groups. Safety analyses are ongoing given a higher number of reported cancers with OCR, but differences must be considered in
The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that their drug be designated as a "Breakthrough Therapy". This designation is primarily based on the early clinical finding of substantial efficacy in s serious medical need indication. A Breakthrough Therapy Designation provides fast track program advantages alongside a frequent FDA guidance on an efficient drug development program. The FDA also makes an organizational commitment to involve experienced reviewers and senior management in such guidance. This presentation provides an overview of Breakthrough Therapy Designation and discusses why CMC aspects can lag-behind clinical development and how this may be addressed.
The time has come to seriously work on leveraging End-of-Phase II for setting regulatory specifications.
1) A phase 3 clinical trial evaluated the efficacy of ocrelizumab in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS) with and without T1 gadolinium-enhancing lesions at baseline.
2) Results showed that ocrelizumab reduced the risk of 12-week and 24-week confirmed disability progression by 24% and 25% respectively compared to placebo in the overall study population.
3) When analyzing subgroups based on presence of T1 lesions at baseline, ocrelizumab reduced risk of disability progression in both subgroups, though the results did not reach statistical significance in the subgroup with lesions at baseline.
Webinar Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH
Speaker: Dr. Richard Lim Boon Leong is a Consultant Palliative Medicine Physician and Head of Palliative Care Unit, Selayang Hospital, Ministry of Health Malaysia.
Inhaled Corticosteroids Increase the Risk of Pneumonia in Patients with Chron...Ming Chia Lee
- The study examined the risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD) using inhaled corticosteroids (ICS) using a national health insurance database in Taiwan.
- It found that ICS use was independently associated with an increased risk of pneumonia in a dose-dependent manner, even after controlling for COPD severity.
- The incidence of pneumonia was higher during periods of ICS use and decreased after discontinuing ICS, while the incidence of acute exacerbations continued to decrease.
- The results provide evidence that ICS should be judiciously prescribed in COPD patients due to the risk of increasing pneumonia.
Improving quality, safety and lives - the Patient Safety Collaborative Programme 2014-2019
Presentation from Chief Nursing Officer for England's Summit 2014
26 November 2014
Efficacy of a medical food in mild Alzheimer’s disease: A randomized, control...Nutricia
1. This randomized, double-blind, controlled trial investigated the effects of a medical food supplement called Souvenaid on cognitive function in 225 patients with mild Alzheimer's disease over 12 weeks.
2. The study found a statistically significant improvement in delayed verbal recall, the primary outcome measure, in the group receiving Souvenaid compared to the control group at 12 weeks.
3. Secondary measures of cognitive function, behavior, functional abilities, and quality of life did not differ between the groups. The medical food was well-tolerated with high compliance among patients.
This document describes a study conducted at a neurogenetics clinic in Argentina that aimed to assess the diagnostic yield of evaluating patients with suspected genetic neurological disorders. The study included 387 patients seen between 2008-2014. Overall, a genetic diagnosis was made in 27.4% of patients. When only considering patients that underwent genetic testing, the diagnostic yield was 45%. For the 140 patients evaluated for progressive ataxia, a genetic cause was identified in 23.5% of patients and 57.5% of patients with a positive family history. The most common causes of ataxia identified were spinocerebellar ataxia types 2, 3 and Friedreich ataxia. This study demonstrates that specialized evaluation can provide a
Care bundles involve grouping several evidence-based interventions together that are aimed at improving patient outcomes when implemented collectively rather than individually. The ventilator bundle includes interventions like DVT prophylaxis and head of bed elevation. Compliance with care bundles is measured using both process measures like completion rates of individual elements as well as outcome measures. Studies show care bundles can improve outcomes for conditions like sepsis when bundle elements are reliably completed for all applicable patients. Ongoing auditing of compliance and outcomes is needed to demonstrate the sustained impact of care bundles.
This document provides guidelines for the diagnosis and treatment of bacterial meningitis. It recommends that patients suspected of having bacterial meningitis receive a lumbar puncture and blood cultures immediately to determine if the CSF formula is consistent with meningitis. It also recommends empirical antibiotic therapy be started before diagnostic tests if lumbar puncture is delayed. The guidelines review evidence on which patients should receive a CT scan before lumbar puncture due to risk of brain herniation. Gram stain, culture and latex agglutination of CSF are recommended diagnostic tests to determine the bacterial etiology of meningitis.
Patients for patient safety. Margaret Murphy. III International Conference on Patient Safety: "Patients for Patient Safety" (Madrid, Ministry of Health and Consumer Affairs, 2007)
Considerations for the Next Wave of COVID-19 DevelopmentMedpace
The document discusses considerations for COVID-19 clinical trial development based on a panel discussion with Medpace experts. It covers three main areas: protocol design elements, endpoint considerations, and operational challenges. For protocol design, experts recommend engaging regulators early, using adaptive designs as the pandemic evolves, and considering disease severity and investigational product type. Endpoint selection should minimize variability and stratify based on disease severity. Operational challenges include site restrictions, recruitment, and adapting quickly to a dynamic environment. The key takeaways are to engage regulators frequently, adapt to changes, and ensure patient safety and data integrity.
Patient safety is the cornerstone of high-quality healthcare services. In the presentation, A summary of the frameworks & practical approaches to improve safety of patient care.
Melissa Hamm is seeking a position utilizing her experience in clinical research and healthcare. She has over 15 years of experience coordinating clinical trials in oncology, hepatology, and infectious diseases. Her resume highlights positions at various hospitals and clinical research organizations where she recruited and consented patients, collected data, tracked regulatory documents, and ensured compliance. Hamm has a Bachelor's degree in Business Administration and is certified as a phlebotomist.
Melissa Hamm is seeking a position utilizing her experience in clinical research and healthcare. She has over 15 years of experience coordinating clinical trials in oncology, hepatology, and infectious diseases. Her resume highlights positions at various academic medical centers coordinating trials related to prostate cancer, hepatitis C, HIV, and other therapeutic areas. She also has experience working in healthcare administration and laboratory support roles. Hamm has a bachelor's degree in business administration and certifications in phlebotomy and clinical research coordination.
Vince & Associates Clinical Research has been providing clinical research services for 15 years. They have an experienced team focusing on quality research data while also prioritizing speed, responsiveness, and accountability for clients. They operate using the Physician Research Model where studies are led by principal investigators involved in all aspects of trials. This approach and their expertise in special populations has led to long-term contracts with the FDA and NIDA.
Webinar Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH
Speaker: Dr. Soo Kok Foong, Emergency Medicine Physician in Sungai Buloh Hospital, Ministry of Health Malaysia.
The document discusses the Early Warning Score (EWS) system, which is a simple scoring method used to rapidly identify clinically deteriorating patients based on 5 physiological parameters. Studies have shown that implementing an EWS protocol can effectively reduce mortality and morbidity for deteriorating patients as well as prevent ICU admissions. The EWS allows for early detection of patients who need urgent medical review and intervention to avoid further physiological deterioration.
Lakeland Regional Health initiated a multi-phase process improvement effort in October 2013 to reduce surgical site infections across their preoperative, intraoperative, and postoperative phases of care. Standardized protocols were implemented, including use of chlorhexidine for skin preparation, standardized antibiotic administration, and monitoring of operating room conditions. This led to a reduction in their surgical site infection rate compared to previous years. The project demonstrated that implementing evidence-based standards can successfully decrease surgical site infections across a large health system.
Patient safety and error reduction approachesLallu Joseph
This document discusses approaches to reducing medical errors and improving patient safety. It begins by defining patient safety and outlining the prevalence of medical errors. It then provides an example of a wrong patient surgery that occurred due to lack of patient identification and unfollowed protocols. The document advocates for a systems approach to error reduction rather than individual discipline. It promotes techniques from human factor engineering like failure mode and effects analysis. Overall, the document argues that senior leadership must support efforts to standardize tasks, reduce handoffs, track performance, and redesign systems to more reliably prevent harm to patients.
- The study compared ocrelizumab (OCR) to placebo in treating primary progressive multiple sclerosis (PPMS) over approximately 3 years. Baseline characteristics were balanced between the treatment groups.
- OCR met the primary endpoint of reducing disability progression confirmed at 12 weeks compared to placebo. Key secondary endpoints including disability progression at 24 weeks, timed walking test, brain lesion volume, and brain volume loss were also significantly improved by OCR compared to placebo.
- Adverse events including infections were more common with OCR, but serious adverse events and discontinuation due to adverse events were similar between groups. Safety analyses are ongoing given a higher number of reported cancers with OCR, but differences must be considered in
The 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that their drug be designated as a "Breakthrough Therapy". This designation is primarily based on the early clinical finding of substantial efficacy in s serious medical need indication. A Breakthrough Therapy Designation provides fast track program advantages alongside a frequent FDA guidance on an efficient drug development program. The FDA also makes an organizational commitment to involve experienced reviewers and senior management in such guidance. This presentation provides an overview of Breakthrough Therapy Designation and discusses why CMC aspects can lag-behind clinical development and how this may be addressed.
The time has come to seriously work on leveraging End-of-Phase II for setting regulatory specifications.
1) A phase 3 clinical trial evaluated the efficacy of ocrelizumab in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS) with and without T1 gadolinium-enhancing lesions at baseline.
2) Results showed that ocrelizumab reduced the risk of 12-week and 24-week confirmed disability progression by 24% and 25% respectively compared to placebo in the overall study population.
3) When analyzing subgroups based on presence of T1 lesions at baseline, ocrelizumab reduced risk of disability progression in both subgroups, though the results did not reach statistical significance in the subgroup with lesions at baseline.
Webinar Series on COVID-19 vaccine: Jointly organized by Malaysian Society of Infection Control and Infectious Diseases (MyICID) & Institute for Clinical Research (ICR), NIH
Speaker: Dr. Richard Lim Boon Leong is a Consultant Palliative Medicine Physician and Head of Palliative Care Unit, Selayang Hospital, Ministry of Health Malaysia.
Inhaled Corticosteroids Increase the Risk of Pneumonia in Patients with Chron...Ming Chia Lee
- The study examined the risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD) using inhaled corticosteroids (ICS) using a national health insurance database in Taiwan.
- It found that ICS use was independently associated with an increased risk of pneumonia in a dose-dependent manner, even after controlling for COPD severity.
- The incidence of pneumonia was higher during periods of ICS use and decreased after discontinuing ICS, while the incidence of acute exacerbations continued to decrease.
- The results provide evidence that ICS should be judiciously prescribed in COPD patients due to the risk of increasing pneumonia.
Improving quality, safety and lives - the Patient Safety Collaborative Programme 2014-2019
Presentation from Chief Nursing Officer for England's Summit 2014
26 November 2014
Efficacy of a medical food in mild Alzheimer’s disease: A randomized, control...Nutricia
1. This randomized, double-blind, controlled trial investigated the effects of a medical food supplement called Souvenaid on cognitive function in 225 patients with mild Alzheimer's disease over 12 weeks.
2. The study found a statistically significant improvement in delayed verbal recall, the primary outcome measure, in the group receiving Souvenaid compared to the control group at 12 weeks.
3. Secondary measures of cognitive function, behavior, functional abilities, and quality of life did not differ between the groups. The medical food was well-tolerated with high compliance among patients.
This document describes a study conducted at a neurogenetics clinic in Argentina that aimed to assess the diagnostic yield of evaluating patients with suspected genetic neurological disorders. The study included 387 patients seen between 2008-2014. Overall, a genetic diagnosis was made in 27.4% of patients. When only considering patients that underwent genetic testing, the diagnostic yield was 45%. For the 140 patients evaluated for progressive ataxia, a genetic cause was identified in 23.5% of patients and 57.5% of patients with a positive family history. The most common causes of ataxia identified were spinocerebellar ataxia types 2, 3 and Friedreich ataxia. This study demonstrates that specialized evaluation can provide a
Care bundles involve grouping several evidence-based interventions together that are aimed at improving patient outcomes when implemented collectively rather than individually. The ventilator bundle includes interventions like DVT prophylaxis and head of bed elevation. Compliance with care bundles is measured using both process measures like completion rates of individual elements as well as outcome measures. Studies show care bundles can improve outcomes for conditions like sepsis when bundle elements are reliably completed for all applicable patients. Ongoing auditing of compliance and outcomes is needed to demonstrate the sustained impact of care bundles.
This document provides guidelines for the diagnosis and treatment of bacterial meningitis. It recommends that patients suspected of having bacterial meningitis receive a lumbar puncture and blood cultures immediately to determine if the CSF formula is consistent with meningitis. It also recommends empirical antibiotic therapy be started before diagnostic tests if lumbar puncture is delayed. The guidelines review evidence on which patients should receive a CT scan before lumbar puncture due to risk of brain herniation. Gram stain, culture and latex agglutination of CSF are recommended diagnostic tests to determine the bacterial etiology of meningitis.
Patients for patient safety. Margaret Murphy. III International Conference on Patient Safety: "Patients for Patient Safety" (Madrid, Ministry of Health and Consumer Affairs, 2007)
Considerations for the Next Wave of COVID-19 DevelopmentMedpace
The document discusses considerations for COVID-19 clinical trial development based on a panel discussion with Medpace experts. It covers three main areas: protocol design elements, endpoint considerations, and operational challenges. For protocol design, experts recommend engaging regulators early, using adaptive designs as the pandemic evolves, and considering disease severity and investigational product type. Endpoint selection should minimize variability and stratify based on disease severity. Operational challenges include site restrictions, recruitment, and adapting quickly to a dynamic environment. The key takeaways are to engage regulators frequently, adapt to changes, and ensure patient safety and data integrity.
Patient safety is the cornerstone of high-quality healthcare services. In the presentation, A summary of the frameworks & practical approaches to improve safety of patient care.
Melissa Hamm is seeking a position utilizing her experience in clinical research and healthcare. She has over 15 years of experience coordinating clinical trials in oncology, hepatology, and infectious diseases. Her resume highlights positions at various hospitals and clinical research organizations where she recruited and consented patients, collected data, tracked regulatory documents, and ensured compliance. Hamm has a Bachelor's degree in Business Administration and is certified as a phlebotomist.
Melissa Hamm is seeking a position utilizing her experience in clinical research and healthcare. She has over 15 years of experience coordinating clinical trials in oncology, hepatology, and infectious diseases. Her resume highlights positions at various academic medical centers coordinating trials related to prostate cancer, hepatitis C, HIV, and other therapeutic areas. She also has experience working in healthcare administration and laboratory support roles. Hamm has a bachelor's degree in business administration and certifications in phlebotomy and clinical research coordination.
Marslyn Clark is a registered nurse with over 20 years of experience in research nursing. She has worked in operating rooms, recovery rooms, and occupational health. Her experience includes conducting clinical trials, recording data for process improvement, and managing workers' compensation cases. She is skilled in multi-tasking, teamwork, attention to detail, and computer applications. Currently she works as an occupational health nurse, overseeing clinical operations and programs.
Carmen Z. Quiñones Concepcion has over 20 years of experience in clinical research, pathology, and medical transcription. She holds a MS in Clinical Research Administration from Walden University and expects to graduate with a Medicine Doctor degree from USAT school of Medicine in June 2017. Her background includes roles as a pathologist assistant, sub-administrator, medical transcriptionist, and X-Ray transcriptionist. She has strong organizational, communication, and problem-solving skills and experience managing projects, teams, and medical records.
Janette Edwards is a medical sales and applications specialist with over 30 years of experience as a nuclear medicine technologist. She has excellent communication, customer service, and critical thinking skills. Her education includes an Associate's Degree in Nuclear Medicine from Bowman Gray School of Medicine and an Associate's Degree in General Studies from Surry Community College. She maintains all necessary certifications and memberships. Currently she is a Clinical Instructor for nuclear medicine students at Forsyth Technical Community College, where she supervises students' clinical experiences.
This document provides a summary of Tatiana B. Lance's professional profile, education, skills, work experience, therapeutic experience, publications, and presentations. She has over 20 years of experience in clinical research and medicine obtained in both Russia and the United States. Her most recent role is as a Central Monitoring Associate for INC Research, where she is responsible for remote monitoring of clinical trials. She aims to obtain a challenging position with a reputable CRO commensurate with her education and experience in bringing new drugs to market and protecting research subjects.
Bridget Keyes has over 20 years of experience in nursing and case management. She is currently the Manager of Case Management at Robert Wood Johnson University Hospital, where she oversees utilization management activities and works to ensure compliance with guidelines. Previously, she held case manager positions at Memorial Sloan Kettering Cancer Center, where she coordinated patient care across settings and payer systems. She has a Bachelor of Science in Nursing, a Bachelor of Arts, an Executive MPA, and is a certified case manager.
This document provides a summary of Melissa Meehan's professional experience and qualifications. She currently works as a Transition Nurse Specialist at UC San Diego Health System, coordinating care for high-risk patients to improve care transitions and eliminate gaps in care. Previously she held several roles coordinating care for patients with conditions such as liver disease, cancer, and infectious diseases. She has over 25 years of experience in clinical research, care coordination, and nursing.
Bryan Bade has over 6 years of experience as a sleep technologist with skills in polysomnography, CPAP/BiPAP, MSLT, pediatrics, vital signs, medical terminology, data entry, patient scheduling, ancillary testing, patient education, and knowledge of HIPAA and JCAHO standards. He has worked as a sleep technologist at Kingman Regional Medical Center in Arizona from 2005-2008 and at Saint Alphonsus Regional Medical Center in Idaho from 2002-2005 where he performed diagnostic sleep studies, maintained equipment and records, and ensured patient care standards. References are available upon request.
Janna Brancato is a research nurse at Yale Medical School and Yale School of Public Health. She has overseen multiple research studies focused on improving diagnosis and treatment of tick-borne diseases since 2012. She has ensured compliance with research standards, optimized subject enrollment and data collection, trained over 500 personnel, and maintained accurate reporting and safety protocols. Her skills include laboratory techniques, data management, and developing research protocols. She has a Bachelor of Science in Nursing from MGH Institute of Health Professions and a Bachelor of Science in Allied Health Sciences from University of Connecticut.
Yaron Gruper is a highly trained biotech professional seeking a new clinical research position combining scientific and management skills. He has over 15 years of experience managing clinical trials from startup to completion in medical devices and pharmaceuticals. His most recent role was Director of Clinical Studies at Theranica Bio-Electronics where he oversaw pivotal neurology studies. He is skilled in site management, data management, regulatory submissions, and publication.
Dawn R. Tucker is a qualified nurse practitioner with over 14 years of experience in direct patient care. She has a Masters in Nursing-Family Nurse Practitioner from Kaplan University and a Bachelor's in Nursing from Excelsior College. Ms. Tucker has extensive clinical experience, including over 700 hours in her FNP program specializing in adult, geriatric, pediatric, OB/GYN and surgical patients. She is licensed as an RN in Florida and will soon be board certified as an ANCC nurse practitioner.
Victor Henry Jr. has experience in human services, health education, and respiratory care. He worked as a cardiac monitor technician at Methodist Healthcare System from 2014 to 2016. He has also volunteered at Martin Luther King Health Center and worked as a respiratory therapist at Sherman Oaks Hospital and the VA Medical Center. Henry has an associate's degree in respiratory therapy, a bachelor's degree in community health, and is currently pursuing a master's degree in human services.
Alicia Sterbakov is a registered nurse with over 20 years of experience in home health care, hospice care, and hospital settings. She has extensive experience managing patient caseloads, coordinating home visits, administering medications, and providing patient education. Her resume highlights her strong clinical skills, ability to collaborate with interdisciplinary teams, and commitment to compassionate, dignified patient care.
Pejman Ferdowsian is a medical doctor seeking a new position. He has over 10 years of experience in various medical specialties including family medicine, internal medicine, surgery, obstetrics/gynecology, pathology, pediatrics, psychiatry, and interventional radiology. He has worked in clinical settings in the US and Canada. Pejman has strong communication, research, and analysis skills. He is currently involved in ongoing medical research and professional development.
Moyette P. Shattock is a certified family nurse practitioner with over 9 years of nursing experience. She holds an MSN from South University and has been certified as an ARNP in Florida since 2016. Her clinical experience includes working as a registered nurse in dialysis, interventional radiology, nursing education, and travel nursing. She has experience managing a variety of patients in primary care, women's health, pediatrics, and nephrology settings during her MSN clinical practicums.
Angel Santana is a highly experienced healthcare professional with over 5 years of experience in home health care. He has obtained numerous certifications including EKG Technician, Phlebotomy, Patient Care Technician, CPR, Nursing Assistant, and Home Health Aide. He is bilingual in English and Spanish and has a proven track record of providing excellent patient care and service. He is seeking a new position where he can utilize his skills and certifications to support patients, medical staff, and the organization.
Donna Alloway has over 17 years of experience as a registered nurse specializing in nephrology, dialysis, and geriatric care. She holds a BSN from the University of South Alabama and has worked in hospitals, clinics, and nursing homes. Her skills include assessments, care planning, patient education, regulatory compliance, and equipment maintenance.
This document is a resume for Maria Reyes-Epondulan seeking a position as a Clinical Laboratory Scientist. She has over 15 years of experience in phlebotomy, medical technologies, and laboratory procedures. Her most recent position was as a Certified Laboratory Scientist 2 at NeoGenomics Laboratory from 2014 to present. She has a Bachelor of Science in Medical Technology and is certified as a CLS, MTA, CPT 1, and in CPR/BLS.
This document is a resume for Susan L. Wiser, RN, BSN, CCRC. It summarizes her extensive nursing experience including over 25 years of experience in clinical research coordination, nursing management, and direct patient care across various clinical settings such as mental health, addiction treatment, corrections, and retina clinical trials. She has coordinated many clinical trials from Phase I-IV and has a track record of meeting or exceeding enrollment goals on every trial.
Similar to Glenda Pearson CV October 2015 - Google Docs (20)
1. GLENDA PEARSON, RN, CRA
ADDRESS: 108 Campion, Dr. Waveland MS 39576 PHONE: 228.671.7903 EMAIL: glendapearson411@gmail.com
CLINICAL RESEARCH ASSOCIATE (CRA)
DECLARE THE PAST, DIAGNOSE THE PRESENT, FORETELL THE FUTURE..HIPPOCRATES
I BELIEVE IN RESEARCH AND ITS' ABILITY TO CURE DISEASE! I HAVE A GREAT PASSION FOR
RESEARCH AND THE
POSITIVE AFFECTS WORKING IN UNITY AS A TEAM HAS ON THE HUMAN SPIRIT! GIVING THOSE
WHO HAVE ENTRUSTED
THEMSELVES TO US, THE CONFIDENCE THAT WE ARE WORKING FOR A POSITIVE STUDY OUTCOME
FOR ALL.
CORE COMPETENCIES
Extensive knowledge of the clinical trial
process
Skilled at rapid conflict resolution
Clinical site management
Ability to work with minimal supervision
Comprehensive knowledge of GCP,
Clinical guidelines,
Clinical Regulatory requirements
Establish and maintain professional
working relationships
Excellent time management skills
Detail oriented
EDUCATION AND CREDENTIALS
1996 Associate’s Degree, Registered Nurse
Pearl River College
2005 CCRC Certified Clinical Research Coordinator
ACRP
2012 Emergency Management Institute
IS00700.a
U.S. Department of Homeland Security
National Incident Management System Certificate (NIMS)
2013 GCP Good Clinical Practice Curriculum
Brookewood, INC
2008 Sixth Edition
Page 1 of 8
2. GLENDA PEARSON, RN, CRA
ADDRESS: 108 Campion, Dr. Waveland MS 39576 PHONE: 228.671.7903 EMAIL: glendapearson411@gmail.com
GCP Reference Guide Review
2013 Medpace Medical Device
Coordinator InForm Training
Version 3, 01Aug2011
2015 CLDCPHealth Literacy
2015 Nutrition & Energy
Education for patients using Chemotherapy medications
PROFESSIONAL EXPERIENCE
2015Present Care Manager
Giving Tree MS
● Responsible for providing comprehensive assessment
● Planning implementation and over evaluation of individual clients needs
● Work with agencies and service providers to facilitate case coordination and
information sharing
● Help the client to understand their conditions and treatment options
● Communicate with physicians and develop working relationship
● Help client and families to make informed decisions
● Review treatment goals and resources
● Provide education and literature about diagnosis
● Participate in the development and implementation of client care policies and
protocols
● Promote effective and efficient utilization of clinical resources
20132014 CCRC
Heart Clinic of Hammond – Hammond La.
● Worked with Principal Investigator to conduct studies in accordance with (
GCP) Good Clinical Practice, (NIH ) National Institutes of Health
,(HIPAA) Health Insurance Portability and Accountability Act and
● ( FDA,)Food and Drug Administration regulations.
● Developed subject recruitment plans
● Developed site processes to comply with appropriate protocol and
regulatory procedures.
Page 2 of 8
3. GLENDA PEARSON, RN, CRA
ADDRESS: 108 Campion, Dr. Waveland MS 39576 PHONE: 228.671.7903 EMAIL: glendapearson411@gmail.com
● Facilitated sponsor site visits, site selection visits, interim monitoring and
study closeouts
● Worked with (FCE) Field Clinical Engineer, Med/Guarding System,
(IMD), Implantable device that collects and analyzes EKG segments to
detect significant changes in ST “Shift” 24 hours a day.
● Education to patients concerning alarms associated with IMD
● Monitored all adverse reactions, data collection, Protocol deviations ,EXD
replacement, maintain study integrity in house monitoring, worked with
PI, to conduct study in accordance with, Declaration of Helsinki and all
applicable regulations.
● Reviewed source documents and subject medical records confirming
records were attributable, legible, contemporaneous, original, and accurate
and complied with 21CFR 58.130 (15) Alcoa governing regulations
● Manually reviewed subject data in EDC.
HIGHLIGHTS:
ESTABLISHED STRONG AND EFFECTIVE WORKING RELATIONSHIPS WITH SPONSOR
AND VENDORS THROUGH OPEN COMMUNICATIONS, BASED ON TRUST, AND COMMITMENT IN A
PROFESSIONAL MANOR.
2006–2010 Clinical Research Coordinator
Northshore Regional Medical Center – Slidell La
● Coordinated with Principal Investigator and Administration to ensure
research was conducted in accordance with FDA guidelines and sponsor
specific protocols.
● Assisted with investigation study selection and project negotiation.
● Attend investigator meetings required or requested by the PI
● Provide support to study coordinators pertaining to issues affecting clinical
trial conduct.
● Maintained SOP.GCP, and ICH guidelines.
● Review and develop a familiarity with the protocol, e.g. study proceedings
and time lines, inclusion, exclusion criteria, confidentiality following all
HIPAA, regulations with regard to patients privacy.
● Assist with submission of accurate and timely closeout documents.
1999Present Community Based Charge Nurse
Hancock Medical Center
Page 3 of 8
4. GLENDA PEARSON, RN, CRA
ADDRESS: 108 Campion, Dr. Waveland MS 39576 PHONE: 228.671.7903 EMAIL: glendapearson411@gmail.com
Bay St. Louis, MS
● Performed physical assessments for patients
● Administration of medications as needed.
● Perform glucose checks,
● Triage, administration of emergency care with stabilization until the
patient is transferred to appropriate unit.
● Responsibilities in preop and postop acute settings include but not
limited to: preop patient assessment,
● Medical HX, current labs, XRays, IV therapy, Vital signs, 02 therapy,
wound care using sterile procedure,pain management .
● Distribution of age appropriate procedure instructions with emphasis for
required followup with treating physicians.
● Immunization and yearly flu immunization program as directed through
communitybased clinic policy and procedures.
● Maintain and update computer literacy on an on going basis.
● Instruct patients with diabetes on insulin pump, insulin use, diet, infection
control, proper exercise.
● Preformed drug screenings and physicals for new employees at Port
Bienville Clinic.
● Maintained Special Needs Shelter in community setting during Hurricane
Katrina!
● Held community outreach Health Fair.
19961999 RN Charge Nurse
Slidell Memorial Hospital Slidell LA
Charge nurse for Rehabilitation Unit
Assigned all patient care, assessment of Code Cart each shift.
● Coordinated patient admissions and transfers.
● Performed Comprehensive physical assessments
● Distribution of medications
● Preformed all blood transfusions
● Lab draws to Central Lines
● Worked with PT, ST and OT to provide safe environment for all patients
● Maintained close working relationships with treating physicians, all staff,
as well as families to facilitate, and educate all involved to reach goals
implemented for patients recovery.
● Monitor all data for unit, monitored patients charts.
Page 4 of 8
5. GLENDA PEARSON, RN, CRA
ADDRESS: 108 Campion, Dr. Waveland MS 39576 PHONE: 228.671.7903 EMAIL: glendapearson411@gmail.com
● Made sure all documents needed were up to date according to all
regulations
● Facilitated all referrals, transfers, and discharge of patients.
HIGHLIGHTS:
✓ As charge nurse I supervised and delegated duties to LPN’s and Nursing
assistants.
PROFESSIONAL DEVELOPMENT
AFFILIATIONS
TECHNICAL SKILLS
Microsoft Office Suite (Word, Excel, and PowerPoint)
Microsoft Publisher
Internet Applications
Various electronic case report form (eCRF) systems, EDC systems and study databases
RESEARCH STUDIES
037–01/ERT156 A prospective, multicenter, doubleblind with inhouse blinding,
randomized, comparative study to evaluate the efficacy, safety, and tolerability of
ertapenem sodium versus piperacillintazobactam in the treatment of complicated
intraabdominal infections in hospitalized adults.
051–356 A longterm safety study of levalbuterol and racemic albuterol in subjects twelve
years of age and older with asthma.
156–03–236 Multicenter randomized, doubleblind, placebocontrolled study to evaluate
the long term efficacy and safety of oral tolvaptan tablets in subjects hospitalized
with worsening congestive heart failure.
322 A multicenter, randomized, doubleblind, doubledummy, parallelgroup efficacy
study comparing 8 weeks of treatment with esomeprazole magnesium (40 mg qd) to
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6. GLENDA PEARSON, RN, CRA
ADDRESS: 108 Campion, Dr. Waveland MS 39576 PHONE: 228.671.7903 EMAIL: glendapearson411@gmail.com
lansoprazole (30 mg qd) for the healing of erosive esophagitis in patients with
moderate or severe erosive esophagitis.
325 A multicenter, randomized, doubleblind, doubledummy, parallelgroup comparison
of the remission rates for once daily treatment with esomeprazole 20 mg and
lansoprazole 15 mg for 6 months in patients whose erosive esophagitis has been
healed.
1502–IMIQ Entitled phase 3b, openlabel effectiveness and safety of imiquimod 5%
topical cream in the treatment of actinic keratosis.
2993–113 A phase 3, randomized, tripleblind, parallelgroup, longterm,
placebocontrolled, multicenter study to examine the effect on glucose control (HbA
1c) of AC2993 given two times a day in subjects with type 2 diabetes mellitus treated
with a sulfonylurea alone.
2993–113E An openlabel extension study of protocol 2993113 to examine the longterm
effect on glucose control (HbA1c) and safety and tolerability of AC2993 given two
times a day in subjects with type 2 diabetes mellitus. 2993–116 A phase 2,
randomized, tripleblind, placebocontrolled, shortterm, doseresponse study to
examine the effect on glucose control and safety and tolerability of AC2993 given
two times a day in subjects with type 2 diabetes mellitus.
2993–119 An openlabel study to examine the longterm effect on glucose control (HbA1c)
and safety and tolerability of AC2993 given two times a day to subject with type 2
diabetes mellitus.
CCIB00212301 a prospective, multinational, multicenter, doubleblind, randomized,
activecontrolled trial to compare the effects of lotrel (amlodipine/benzapril) to
benzapril and hydrochlorothiazide combined on the reduction of cardiovascular
morbidity and mortality in patients with high risk hypertension.
D9619C00001 A multicenter, randomized, doubleblind, parallelgroup,
placebocontrolled efficacy study comparing 4 weeks of treatment with
esomeprazole 20 mg qd for the resolution of upper abdominal pain in patients with
symptomatic gastroesophageal reflux disease (sGERD).
D961AC00001 A multicenter, randomized, doubleblind, placebocontrolled efficacy study
comparing 4 weeks of treatment with esomeprazole 20mg qd and 40 mg qd to
Page 6 of 8
7. GLENDA PEARSON, RN, CRA
ADDRESS: 108 Campion, Dr. Waveland MS 39576 PHONE: 228.671.7903 EMAIL: glendapearson411@gmail.com
placebo qd in patients with heartburn and sleep disturbances associated with
gastroesophageal reflux disease (GERD).
EFC4736 A randomized, doubleblind, placebocontrolled, fixeddose, multicenter study of
weightreducing effects and safety of SR141716 in obese patients with type 2
diabetes.
GLP107294: A 17week, parallelgroup, doubleblind, randomized, placebocontrolled,
multicenter, doseranging study to evaluate the efficacy, safety, and tolerability of
four doses of GSK716155, with Byetta as an openlabel active reference, in subjects
with type 2 diabetes mellitus.
HOE 901/4033 (GOAL A1c) a diabetic study.
LOFBIV–PCAP–003 A phase 3 (PRI/LOFINT1) a multicenter, randomized, openlabel,
comparative study to compare the efficacy and safety of levofloxacin and standard
of care therapy in the treatment of children with communityacquired pneumonia in
the hospitalized or outpatient setting (RWJ25213097).
LOFBO–LTSS–001 Phase 3 (PRI/LOF–INT–4) a multicenter, longterm,
activesurveillance study of musculoskeletal disorder that occur after initiating a
course of levofloxacin (RWJ–25213–097) or nonfluoroquinolone therapy for acute
infectious diseases in children who were enrolled in phase 3 clinical trials involving
levofloxacin therapy.
LOFBO–OTMD–002 Phase 3 (PRI/LOF–INT–2) a multicenter, randomized, comparative
study of evaluate the efficacy and safety of levofloxacin in the treatment of children
who have recurrent and/or persistent acute otitis media (RWJ–25213–097).
S3B0048 A 12week, randomized doubleblind, placebocontrolled study with PRN bid and
fixed dosing regimens of alosetron in female subjects with severe
diarrheapredominant irritable bowel syndrome who have failed conventional
therapy.
SD–004–0758 (Pulmicort Respules) Rates of seroconversion following varicella
vaccination of asthmatic children between the ages of one and eight years treated
with Pulmicort Respules versus nonsteroidal conventional asthma therapy.
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