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Derek smith resume 7

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I have recently relocated to the Denver, Colorado area and I am actively seeking a position, in research, that can challenge and utilize the professional knowledge I have acquired over the past four years. I am a self motivated, ambitious young professional who has worked very hard to become an effective asset and team member to each organization which I have been a part of. Since my graduation with a BS Clinical Research, I have worked in a variety of positions including corporate CRO research (INC Research), direct clinical care (Nursing Assistant at UNC and Duke Hospitals), and most recently, Clinical Research on the site level with the Duke University Cardiothoracic Surgery Research Team. My previous team lead and research practice manager, included as references on my resume, will likely cite my ability and willingness to learn quickly, interact with subjects/patients in a personable manner, and develop productive working relationships with my team members. I pride myself on my work ethic and enjoy working around others that inspire that same dedication.

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Derek D. Smith
3234 W 23rd
Ave.
Denver Co, 80211
derek.d.smith3@gmail.com
(919)624-7256
I am an ambitious, self-motivated, research professional in Denver, Colorado looking for the right
position to utilize and challenge the expertise I have gained through dedication to education and the
clinical research profession.
FORMAL EDUCATION
Bachelor of Science in Clinical Research August 2014
Campbell University, Buies Creek, NC
High School Diploma June 2008
Green Hope High School, Morrisville, NC
PROFESSIONAL EXPERIENCE
Clinical Trials Assistant II November 2015 – August 2016
Cardio-Thoracic Surgery Office of Clinical Research
Duke University Hospital
Durham, NC
Team Contributions
 Develop project timelines, track milestones
 Maintain records of weekly progressions and projections
 Take meeting minutes twice weekly for NIH review
 Upload and update meeting agenda weekly
 Create and update master CT surgery screening log daily
 Determine eligibility using procedures - imaging (CT and Echo) – Hx
 Plan social events for team building / celebrations
 Train new team members on all CTA processes
Subject/Study Responsibilities
 Extract, label and archive source documents from MaestroCare.
 Enter data and upload source documents into EDC databases: eClinical – REDCap – InChoir.
 Redact all 18 HIPAA patient identifiers from source documents
 Administer and record audio of neurocognitive testing - stroke scales – questionnaires - delirium
assessments.
 Collect, label, and spin tissue and blood samples in research lab.
2
 Routinely package and ship biological materials to sponsors and laboratory vendors.
 Consent eligible subjects for low-risk studies
 Enter data and maintain the International Registry of Aortic Dissections
 Navigate Duke eIRB to submit and receive approvals: amendments – continuing reviews –
safety events.
 Track all changes made to informed consents and protocols in the eIRB
 Ensure the study materials and drug kits: timely shipped – received – maintained properly.
Monitoring
 Organize and maintain regulatory and subject binders to remain audit ready.
 Assist in hosting site audits: FDA – NIH – industry sponsors.
 Request CRA access to subject medical charts.
 Close out CRA’s remote monitoring queries in EDC
 Collaborate with CRAs to document: location – completion – and accuracy of study related
documents.
 Ensure the study materials and drug kits: timely shipped – received – maintained properly.
 Collaborate with Investigational Drug Services: review and track drug accountability.
Certified Nursing Assistant I (Nurse Aide) April 2015 – September 2015
UNC Memorial Hospital 7-3
Chapel Hill, NC
 Assist nurses, Occupational Therapists, PhysicalTherapists, and Speech Therapists on the
Rehabilitation floor of UNC Memorial Hospital.
 Obtain and record vital signs, obtain and record blood glucose levels.
 Obtain samples of patient input and output for laboratory analysis.
 Assist with feeding, ambulation, transfers, toileting, TED stockings, dressing, changing linens among
other duties.
 Discharge and admission of patients.
Certified Nursing Assistant I March 2015 – August 2015
Duke Regional Hospital 4-1
Durham, NC
 Assist nurses on the General Medicine floor of Duke Regional.
 Obtain and record vital signs, obtain and record blood glucose levels.
 Obtain samples of patient input and output for laboratory analysis.
 Assist with feeding, ambulation, transfers, toileting, TED stockings, dressing, changing linens among
other duties.
 Discharge and admission of patients.
3
Quality Assurance Intern at INC Research May 2014 – August 2014
Raleigh, NC
 Recorded audit findings in INC Resolution.
 Took “meeting minutes” during audits for later reference.
 Compiled team lists, training files, and gap reports.
 Worked full-time with a five member team to conduct internal audits, mock FDA audits, and
site audits.
 Compiled regulatory binders for auditors to use as a reference.
 Used RAVE database to enter study site information.
APPLICABLE COURSEWORK
Advanced Human Physiology
Biostatistics Medical Terminology
Clinical Biochemistry
Data Management
General Chemistry I/II
General Physics I
Human Anatomy and Physiology
Interpersonal Skills
Microbiology and Immunology
New Product Development
Organic Chemistry I/II
Pharmacology
Physical & Clinical Assessment
Regulatory Affairs I/II
Scientific and Technical Writing
Scientific Literature Seminar I/II
ACADEMIC HONORS & AWARDS
 Campbell University Scott-Ellis Scholarship 2011 - 2014
 Dean’s List Appalachian State University 2008 – 2009
CERTIFICATIONS
 Duke Surgery Clinical Research Unit Informed Consent Certified January 2016
 Collaborative Institutional Training Initiative (CITI) Biomedical Research November 2015
o IRB
o Informed Consent
o Vulnerable Populations: Prisoners, Children, and Pregnant Women
o FDA regulated research
o Conflict of Interest
 Collaborative Institutional Training Initiative (CITI) Good Clinical Practice November 2015
o New Drug Development
o ICH GCP E6 and FDA
o Medical Devices
o Detecting and Evaluating Adverse Events
4
o Reporting Serious Adverse Events
o Monitoring by Industry Sponsors
o Audits and Inspections of Clinical Trial
 Collaborative Institutional Training Initiative (CITI) Research Involving November 2015
Children
 HIPAA Privacy and Security for Clinicians Certification May 2015
 Healthcare Provider CPR/BLS Certified August 2014
 Certified Nurse Aide I North Carolina October 2014
o 100 hrs. Course Instruction
o 60 hrs. Clinical (WakeMed)
o NNAAP Skills and Written
 Healthcare Provider CPR/BLS Certified August 2014
COMMUNITY ACTIVITIES
 Farmer Foodshare August 2015 - Present
 Clinical Research Club Campbell University August 2012, 2013, 2014
 Relay for Life May, 2012
 Health and Hunger Coalition Volunteer September, 2010
 Adventurers Volunteer Week (Camp Trinity) July 2007, July 2010
 Appalachian Service Project (ASP) May 2006, May 2007, May 2008
REFERENCES
Stacey Welsh RN
Clinical Research Coordinator III
Cardio-thoracic Surgery
Duke University Medical Center
stacey.welsh@duke.edu
(919)-452-2271
Beth Hollister RN
Research Practice Manager
Surgery Chairman
Duke University Medical Center
(919)-681-2172
Holly Gunning RN
Clinical Nurse II 7 Bedtower - Rehabilitation
UNC Memorial Hospital
Holly.Gunning@unchealth.edu
(919)730-8454
5
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Derek smith resume 7

  • 1. Derek D. Smith 3234 W 23rd Ave. Denver Co, 80211 derek.d.smith3@gmail.com (919)624-7256 I am an ambitious, self-motivated, research professional in Denver, Colorado looking for the right position to utilize and challenge the expertise I have gained through dedication to education and the clinical research profession. FORMAL EDUCATION Bachelor of Science in Clinical Research August 2014 Campbell University, Buies Creek, NC High School Diploma June 2008 Green Hope High School, Morrisville, NC PROFESSIONAL EXPERIENCE Clinical Trials Assistant II November 2015 – August 2016 Cardio-Thoracic Surgery Office of Clinical Research Duke University Hospital Durham, NC Team Contributions  Develop project timelines, track milestones  Maintain records of weekly progressions and projections  Take meeting minutes twice weekly for NIH review  Upload and update meeting agenda weekly  Create and update master CT surgery screening log daily  Determine eligibility using procedures - imaging (CT and Echo) – Hx  Plan social events for team building / celebrations  Train new team members on all CTA processes Subject/Study Responsibilities  Extract, label and archive source documents from MaestroCare.  Enter data and upload source documents into EDC databases: eClinical – REDCap – InChoir.  Redact all 18 HIPAA patient identifiers from source documents  Administer and record audio of neurocognitive testing - stroke scales – questionnaires - delirium assessments.  Collect, label, and spin tissue and blood samples in research lab.
  • 2. 2  Routinely package and ship biological materials to sponsors and laboratory vendors.  Consent eligible subjects for low-risk studies  Enter data and maintain the International Registry of Aortic Dissections  Navigate Duke eIRB to submit and receive approvals: amendments – continuing reviews – safety events.  Track all changes made to informed consents and protocols in the eIRB  Ensure the study materials and drug kits: timely shipped – received – maintained properly. Monitoring  Organize and maintain regulatory and subject binders to remain audit ready.  Assist in hosting site audits: FDA – NIH – industry sponsors.  Request CRA access to subject medical charts.  Close out CRA’s remote monitoring queries in EDC  Collaborate with CRAs to document: location – completion – and accuracy of study related documents.  Ensure the study materials and drug kits: timely shipped – received – maintained properly.  Collaborate with Investigational Drug Services: review and track drug accountability. Certified Nursing Assistant I (Nurse Aide) April 2015 – September 2015 UNC Memorial Hospital 7-3 Chapel Hill, NC  Assist nurses, Occupational Therapists, PhysicalTherapists, and Speech Therapists on the Rehabilitation floor of UNC Memorial Hospital.  Obtain and record vital signs, obtain and record blood glucose levels.  Obtain samples of patient input and output for laboratory analysis.  Assist with feeding, ambulation, transfers, toileting, TED stockings, dressing, changing linens among other duties.  Discharge and admission of patients. Certified Nursing Assistant I March 2015 – August 2015 Duke Regional Hospital 4-1 Durham, NC  Assist nurses on the General Medicine floor of Duke Regional.  Obtain and record vital signs, obtain and record blood glucose levels.  Obtain samples of patient input and output for laboratory analysis.  Assist with feeding, ambulation, transfers, toileting, TED stockings, dressing, changing linens among other duties.  Discharge and admission of patients.
  • 3. 3 Quality Assurance Intern at INC Research May 2014 – August 2014 Raleigh, NC  Recorded audit findings in INC Resolution.  Took “meeting minutes” during audits for later reference.  Compiled team lists, training files, and gap reports.  Worked full-time with a five member team to conduct internal audits, mock FDA audits, and site audits.  Compiled regulatory binders for auditors to use as a reference.  Used RAVE database to enter study site information. APPLICABLE COURSEWORK Advanced Human Physiology Biostatistics Medical Terminology Clinical Biochemistry Data Management General Chemistry I/II General Physics I Human Anatomy and Physiology Interpersonal Skills Microbiology and Immunology New Product Development Organic Chemistry I/II Pharmacology Physical & Clinical Assessment Regulatory Affairs I/II Scientific and Technical Writing Scientific Literature Seminar I/II ACADEMIC HONORS & AWARDS  Campbell University Scott-Ellis Scholarship 2011 - 2014  Dean’s List Appalachian State University 2008 – 2009 CERTIFICATIONS  Duke Surgery Clinical Research Unit Informed Consent Certified January 2016  Collaborative Institutional Training Initiative (CITI) Biomedical Research November 2015 o IRB o Informed Consent o Vulnerable Populations: Prisoners, Children, and Pregnant Women o FDA regulated research o Conflict of Interest  Collaborative Institutional Training Initiative (CITI) Good Clinical Practice November 2015 o New Drug Development o ICH GCP E6 and FDA o Medical Devices o Detecting and Evaluating Adverse Events
  • 4. 4 o Reporting Serious Adverse Events o Monitoring by Industry Sponsors o Audits and Inspections of Clinical Trial  Collaborative Institutional Training Initiative (CITI) Research Involving November 2015 Children  HIPAA Privacy and Security for Clinicians Certification May 2015  Healthcare Provider CPR/BLS Certified August 2014  Certified Nurse Aide I North Carolina October 2014 o 100 hrs. Course Instruction o 60 hrs. Clinical (WakeMed) o NNAAP Skills and Written  Healthcare Provider CPR/BLS Certified August 2014 COMMUNITY ACTIVITIES  Farmer Foodshare August 2015 - Present  Clinical Research Club Campbell University August 2012, 2013, 2014  Relay for Life May, 2012  Health and Hunger Coalition Volunteer September, 2010  Adventurers Volunteer Week (Camp Trinity) July 2007, July 2010  Appalachian Service Project (ASP) May 2006, May 2007, May 2008 REFERENCES Stacey Welsh RN Clinical Research Coordinator III Cardio-thoracic Surgery Duke University Medical Center stacey.welsh@duke.edu (919)-452-2271 Beth Hollister RN Research Practice Manager Surgery Chairman Duke University Medical Center (919)-681-2172 Holly Gunning RN Clinical Nurse II 7 Bedtower - Rehabilitation UNC Memorial Hospital Holly.Gunning@unchealth.edu (919)730-8454
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