The document lists 20 clinical trial studies where the author was the lead recruiter or part of the recruitment team. The studies were conducted by Advanced Biomedical Research and took place in New Jersey, United States.
Ultimate Guide to Clinical Trial CostsKunal Sampat
Want to create a comprehensive clinical trial budget? Or ever wondered how much a clinical study should cost? Here is a complete presentation on all clinical trial costs.
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to KnowTrialJoin
This document provides an overview of the key components of a clinical trial monitoring plan and basic monitoring visits that a clinical research associate (CRA) needs to be aware of. It discusses the main parts of a monitoring plan including CRA site assignments, guidelines, visit timelines, and types of visits. It also explains the differences between traditional and risk-based monitoring approaches. Finally, it outlines the basic monitoring visits that occur, including site selection, initiation, regular monitoring, and close-out visits. The document is intended to educate both new and experienced CRAs on monitoring best practices.
This document discusses quality assurance in physician office laboratories. It provides guidance on developing a quality assurance program that meets CLIA requirements. The summary is:
The document outlines key areas to assess in a quality assurance program, including the relationship between patient information and test results, personnel competency, communication processes, complaint handling, staff training, and record keeping. It provides examples of how to evaluate each area and ensure corrective actions are taken when issues arise. The goal of a quality assurance program is to continuously monitor and improve all aspects of the total testing process to provide quality patient care.
This document provides information on quality assurance requirements for physician office laboratories. It discusses the key areas that must be addressed in a quality assurance program, including patient test management, quality control, proficiency testing, and corrective action processes. The summary discusses how quality assurance acts as an umbrella that covers pre-analytical, analytical, and post-analytical phases of testing and aims to continuously improve patient care through monitoring policies, procedures, and identifying issues. Laboratories must have written procedures to evaluate the total testing process, identify and resolve problems, and ensure accurate and reliable test result reporting.
This document provides information about clinical research careers and training opportunities in clinical research. It outlines the educational requirements and career paths for roles in clinical research, such as clinical research associates, clinical data managers, project managers, and regulatory officers. It also describes a clinical research training institute in India called Clinwell Kriger Training & Research Institute that offers classroom, online, and hands-on training programs to prepare students for careers in clinical research.
This review article critiques the United States Preventive Services Task Force's (USPSTF) recommendation against testicular cancer (TCa) screening, which currently holds a 'D' grade. The authors analyze the evidence and methods used by the USPSTF to make this recommendation. They find logical inconsistencies and a lack of evidence to support a conclusive 'D' grade. Considering the flaws in methodology and lack of sufficient evidence, the authors argue the recommendation should be changed to an 'I' statement, indicating the harms and benefits of TCa screening are indeterminate. The purpose is to reassess the value of TCa screening and encourage further research on its efficacy and ability to prevent cancer mortality
Ultimate Guide to Clinical Trial CostsKunal Sampat
Want to create a comprehensive clinical trial budget? Or ever wondered how much a clinical study should cost? Here is a complete presentation on all clinical trial costs.
Monitoring Plan and Basic Monitoring Visits: Everything that a CRA Needs to KnowTrialJoin
This document provides an overview of the key components of a clinical trial monitoring plan and basic monitoring visits that a clinical research associate (CRA) needs to be aware of. It discusses the main parts of a monitoring plan including CRA site assignments, guidelines, visit timelines, and types of visits. It also explains the differences between traditional and risk-based monitoring approaches. Finally, it outlines the basic monitoring visits that occur, including site selection, initiation, regular monitoring, and close-out visits. The document is intended to educate both new and experienced CRAs on monitoring best practices.
This document discusses quality assurance in physician office laboratories. It provides guidance on developing a quality assurance program that meets CLIA requirements. The summary is:
The document outlines key areas to assess in a quality assurance program, including the relationship between patient information and test results, personnel competency, communication processes, complaint handling, staff training, and record keeping. It provides examples of how to evaluate each area and ensure corrective actions are taken when issues arise. The goal of a quality assurance program is to continuously monitor and improve all aspects of the total testing process to provide quality patient care.
This document provides information on quality assurance requirements for physician office laboratories. It discusses the key areas that must be addressed in a quality assurance program, including patient test management, quality control, proficiency testing, and corrective action processes. The summary discusses how quality assurance acts as an umbrella that covers pre-analytical, analytical, and post-analytical phases of testing and aims to continuously improve patient care through monitoring policies, procedures, and identifying issues. Laboratories must have written procedures to evaluate the total testing process, identify and resolve problems, and ensure accurate and reliable test result reporting.
This document provides information about clinical research careers and training opportunities in clinical research. It outlines the educational requirements and career paths for roles in clinical research, such as clinical research associates, clinical data managers, project managers, and regulatory officers. It also describes a clinical research training institute in India called Clinwell Kriger Training & Research Institute that offers classroom, online, and hands-on training programs to prepare students for careers in clinical research.
This review article critiques the United States Preventive Services Task Force's (USPSTF) recommendation against testicular cancer (TCa) screening, which currently holds a 'D' grade. The authors analyze the evidence and methods used by the USPSTF to make this recommendation. They find logical inconsistencies and a lack of evidence to support a conclusive 'D' grade. Considering the flaws in methodology and lack of sufficient evidence, the authors argue the recommendation should be changed to an 'I' statement, indicating the harms and benefits of TCa screening are indeterminate. The purpose is to reassess the value of TCa screening and encourage further research on its efficacy and ability to prevent cancer mortality
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...SOCRA CCRP Certification
SOCRA study guide - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification.
Defining a Central Monitoring Capability: Sharing the Experience of TransCele...www.datatrak.com
Central monitoring, on-site monitoring, and off-site monitoring provide an integrated approach to clinical trial quality management. TransCelerate distinguishes central monitoring from other types of central data review activities and puts it in the context of an overall monitoring strategy. Any organization seeking to implement central monitoring will need people with the right skills, technology options that support a holistic review of study-related information, and adaptable processes. There are different approaches actively being used to implement central monitoring. This article provides a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. The desired outcomes include earlier, more predictive detection of quality issues. This paper describes the initial implementation steps designed to learn what organizational capabilities are necessary.
Basic terminologies in Clinical trials.pptxsreesujithra
This document defines key terms related to clinical study protocols. It provides definitions for terms such as protocol, efficacy, safety, study start date, first posted, first submitted, arm, eligibility criteria, inclusion/exclusion criteria, healthy volunteer, group, control group, experimental group, and placebo. Definitions are sourced from clinicaltrials.gov and FDA.gov glossaries of clinical research terms.
This document lists numerous clinical research positions available at different locations, including remote and various cities in the US. The positions include clinical project managers, clinical research associates, clinical trial managers and assistants, and other clinical operations roles. Most positions are permanent full-time employees but some are contractors or daily rate contracts. Locations range from remote to various cities on the west coast, east coast and midwest.
This document discusses challenges and strategies related to drawing blood from drug addicts. It notes that drug addicts often have scarred and sclerosed veins due to frequent injections that are difficult to locate and access. It provides solutions such as searching for veins in atypical sites with physician permission, and establishing clear policies on drawing from non-standard sites. The document also notes that drug users often suggest using veins that are not the safest choice, and recommends ignoring their suggestions and using one's own judgment to select the best vein. Safety devices that shield needles after use are also recommended to avoid accidental needlestick injuries.
This document discusses key components of quality management systems for clinical research. It defines quality as compliance or conformance to rules, regulations, guidance, specifications or requirements set by internal or external customers for products, processes or services. For clinical research specifically, quality means data, procedures, processes and activities adhere to expectations of honesty, integrity, accuracy and completeness. The document also distinguishes between quality control, which inspects and certifies quality through control systems, and quality assurance, which designs quality systems and assesses system performance through independent auditing.
The document provides information about audits, inspections, and compliance from the perspective of a Contract Research Organization (CRO). It discusses what a CRO is and different types of CROs. It outlines the importance of having a structured compliance plan and ensuring compliance with Good Laboratory/Clinical/Manufacturing Practices, applicable rules, regulations, and guidelines. The document emphasizes that quality control, monitoring, auditing, and inspections are necessary to ensure compliance and pass regulatory inspections. It provides tips for sites on preparing for and handling inspections by regulatory authorities like the FDA.
This document provides information about CARE Worldwide Inc, a clinical research organization that conducts clinical trials. It describes CARE's global network of clinical trial sites and staff, including principal investigators, clinical research associates, clinical data managers, and other roles. It also discusses the clinical trial process, importance of training for clinical research professionals, and career opportunities in the field. The goal is to support pharmaceutical and medical device companies through quality clinical trials.
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Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...SOCRA CCRP Certification
SOCRA study guide - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification.
Defining a Central Monitoring Capability: Sharing the Experience of TransCele...www.datatrak.com
Central monitoring, on-site monitoring, and off-site monitoring provide an integrated approach to clinical trial quality management. TransCelerate distinguishes central monitoring from other types of central data review activities and puts it in the context of an overall monitoring strategy. Any organization seeking to implement central monitoring will need people with the right skills, technology options that support a holistic review of study-related information, and adaptable processes. There are different approaches actively being used to implement central monitoring. This article provides a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. The desired outcomes include earlier, more predictive detection of quality issues. This paper describes the initial implementation steps designed to learn what organizational capabilities are necessary.
Basic terminologies in Clinical trials.pptxsreesujithra
This document defines key terms related to clinical study protocols. It provides definitions for terms such as protocol, efficacy, safety, study start date, first posted, first submitted, arm, eligibility criteria, inclusion/exclusion criteria, healthy volunteer, group, control group, experimental group, and placebo. Definitions are sourced from clinicaltrials.gov and FDA.gov glossaries of clinical research terms.
This document lists numerous clinical research positions available at different locations, including remote and various cities in the US. The positions include clinical project managers, clinical research associates, clinical trial managers and assistants, and other clinical operations roles. Most positions are permanent full-time employees but some are contractors or daily rate contracts. Locations range from remote to various cities on the west coast, east coast and midwest.
This document discusses challenges and strategies related to drawing blood from drug addicts. It notes that drug addicts often have scarred and sclerosed veins due to frequent injections that are difficult to locate and access. It provides solutions such as searching for veins in atypical sites with physician permission, and establishing clear policies on drawing from non-standard sites. The document also notes that drug users often suggest using veins that are not the safest choice, and recommends ignoring their suggestions and using one's own judgment to select the best vein. Safety devices that shield needles after use are also recommended to avoid accidental needlestick injuries.
This document discusses key components of quality management systems for clinical research. It defines quality as compliance or conformance to rules, regulations, guidance, specifications or requirements set by internal or external customers for products, processes or services. For clinical research specifically, quality means data, procedures, processes and activities adhere to expectations of honesty, integrity, accuracy and completeness. The document also distinguishes between quality control, which inspects and certifies quality through control systems, and quality assurance, which designs quality systems and assesses system performance through independent auditing.
The document provides information about audits, inspections, and compliance from the perspective of a Contract Research Organization (CRO). It discusses what a CRO is and different types of CROs. It outlines the importance of having a structured compliance plan and ensuring compliance with Good Laboratory/Clinical/Manufacturing Practices, applicable rules, regulations, and guidelines. The document emphasizes that quality control, monitoring, auditing, and inspections are necessary to ensure compliance and pass regulatory inspections. It provides tips for sites on preparing for and handling inspections by regulatory authorities like the FDA.
This document provides information about CARE Worldwide Inc, a clinical research organization that conducts clinical trials. It describes CARE's global network of clinical trial sites and staff, including principal investigators, clinical research associates, clinical data managers, and other roles. It also discusses the clinical trial process, importance of training for clinical research professionals, and career opportunities in the field. The goal is to support pharmaceutical and medical device companies through quality clinical trials.
Similar to Some previous studies that I was lead Recruiter on or a part of the Recruitment Team (9)
Some previous studies that I was lead Recruiter on or a part of the Recruitment Team
1. Some previous studies that I was lead Recruiter on or a part of the Recruitment Team.
– ABR
https://clinicaltrials.gov/ct2/show/NCT00910455?term=advanced+biomedical+research&rank=2
https://clinicaltrials.gov/ct2/show/NCT00516659?term=advanced+biomedical+research&rank=1
https://clinicaltrials.gov/ct2/show/NCT00754962?term=advanced+biomedical+research&rank=3
https://clinicaltrials.gov/ct2/show/NCT01321515?term=advanced+biomedical+research&rank=4
https://clinicaltrials.gov/ct2/show/NCT00695071?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=22
https://clinicaltrials.gov/ct2/show/NCT00919867?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=25
https://clinicaltrials.gov/ct2/show/NCT00901576?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=26
https://clinicaltrials.gov/ct2/show/NCT00896077?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=27
https://clinicaltrials.gov/ct2/show/NCT00516659?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=3
https://clinicaltrials.gov/ct2/show/NCT00910455?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=4
https://clinicaltrials.gov/ct2/show/NCT00754962?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=5
https://clinicaltrials.gov/ct2/show/NCT00532467?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=7
https://clinicaltrials.gov/ct2/show/NCT00461370?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=8
https://clinicaltrials.gov/ct2/show/NCT00064415?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=14
https://clinicaltrials.gov/ct2/show/study/NCT00425256?term=advanced+biomedical+research&state1=
NA%3AUS%3ANJ&rank=15&show_locs=Y#locn
https://clinicaltrials.gov/ct2/show/NCT00749632?term=advanced+biomedical+research&state1=NA%3A
US%3ANJ&rank=21