1. Gw yndolyn Carver, B.S. (919) 672-5416
Gwyndolyn Carver, B.S., Clinical Research Professional 703 Burrell Road
Durham, NC 27703
919.672.5416
porphyrion3421@yahoo.com
CORE COMPETENCIES
Drug Safety, Data Management, Clinical Monitoring Budget negotiations and contracts
Study start-up Source document review
Case management planning IRB and Regulatory document review
Project leadership Investigator meetings and presentations
Vendor and Client relations Tracking and metrics
Career Objective
Implement my fifteen years of clinical research experience in a Drug Safety role with a company that focuses on
the protection of human subjects while providing excellent Client service. I also desire to learn and grow;
furthering my expertise and knowledge in pharmacovigilance.
Education
B.S. Food Science: North Carolina A & T State University, Greensboro, NC
Therapeutic Areas of Experience Technologies
Oncology Multiple Sclerosis Chronic Kidney Disease InForm and Medidata RAVE
Ear, nose, throat Obesity Medical Devices Argus, Arisg, Clintrial
Substance abuse Ophthalmology Infectious Disease MS Office Suite
Clinical Research Experience
May 2015 - August 2015
Safety Data Administrator
Drug Safety Alliance - Remote
 Selected by management for QC role in SAE case processing.
 Reduced data errors to Client by reviewing processed safety cases.
 Assisted in safety case processing and data entry when needed using ARGUS.
 Reported daily metrics to management and maintained study database insuring all data were clean and
updated.
 Assisted upper management with preparations for client audits.
December 2014 - April 2015
Safety Specialist
PPD - Morrisville, NC (Green Key Resources)
 Responsible for coordinating and performing adverse event (SAE/AE) triage
 Responsible for full-scope data entry into PPD-owned or client provided adverse event database
 Reviewed ICRS's for quality, consistency and accuracy
 Followed up with reporter and/or associated HCP, tracking of reports, and reporting activities
 Coded adverse event terms and write narratives according to client convention
 Assisted with preparation and review of regulatory reports

2. Gw yndolyn Carver, B.S. (919) 672-5416
 Reviewed literature articles and processed AE reports from literature per program and regulatory
requirements
 Maintained knowledge and understanding of in-house client-provided SOPs and current regulations
 Effectively communicated with team members, client contacts and adverse event reporters
August 2014 - October 2014
Safety Officer II
Theorem Clinical - Remote (Biopoint, Inc.)
 Reviewed and processed clinical safety data for a cardiac medical device study.
 Review included initial and follow up AE's and SAE's in entered into Medidata RAVE as well as site-
provided source documents.
 Queried sites for clinically significant information missing from initial and follow-up reports.
 Prepared reports for Medical Monitor review.
 Completed SAE notifications and final case submissions to Sponsor.
 Assessed expectedness, relationship and seriousness of events for presentation to Clinical Events
Committee and Sponsor.
October 2013 – August 2014
Contract Safety Case Manager
Drug Safety Alliance - Durham, NC (Advanced Recruiting Partners, LLC)
 Selected by management for an upper-level case processing role.
 Extracted, analyzed and processed adverse event data from clinical and post-marketing sources.
 Appropriately integrated all case-related information into the global ARISg safety database.
 Composed narratives, queries, and attached safety letters, where applicable.
 Ensured the timely submission of reports to global regulatory agencies.
 Reviewed, entered and verified follow-up information from various sources.
December 2012 - March 2013
Safety Surveillance Associate II
Duke Cancer Institute - Durham, NC (Kelly Scientific)
 Performed high-level clinical review of SAE cases and Investigational New Drug Safety Reports.
 Determined which reports were appropriate for expedited reporting per federal guidelines.
 Composed medically relevant clinical case narratives.
 Determined expectedness against appropriate label, IB, and ICF.
 Oversaw entry of reports into tracking system and other applicable databases.
 Queried sites for clinically significant information missing from safety reports.
 Provided independent QC of safety reports for other members of the group.
 Performed independent review of clinical study documents, including protocols, case report forms and
clinical study reports.
October 2012 - December 2012
Contract Drug Safety Case Manager
Drug Safety Alliance - Morrisville, NC
 Processed individual case safety reports associated with clinical and post marketed drugs and medical
devices
 Provided Client with case notifications and regulatory submissions.
 Responsible for case assessment and full narrative writing of individual case safety reports
 Tracked operational metrics, providing client service support, and ensuring quality of work.

3. Gw yndolyn Carver, B.S. (919) 672-5416
November 2011 - June 2012
Associate Safety Specialist
Quintiles Lifecycle Safety Group - Morrisville, NC (Clinforce)
 Reviewed and processed clinical and post marketing safety data within Sponsor timelines.
 Assessed individual safety case data for seriousness and reportability to regulatory authorities.
 Coded relevant medical terminology and wrote comprehensive safety narratives per Sponsor guidelines .
 Communicated with sites and generated queries to resolve data issues.
 Generated daily status reports and project metrics to management.
 Attended regular team meetings to receive instructions and assist in implementation of new processes .
 Responded to Sponsor queries and requests by updating safety information and finalizing narratives for
case closure.
October 2010 - November 2011
Medical Records Reviewer, Consultant
Garretson Firm Resolution Group - Remote
 Used cumulative medical knowledge to confirm diagnoses of various respiratory diseases in the mass tort
claims of the September 11 terrorist attack.
 Reviewed medical documents of first responders and other victims including operative and pathology
reports, laboratory reports, medical histories, and discharge summaries to confirm disease diagnoses.
 Documented review findings consistent with the terms of the settlement program and as specified with
internal process guidelines.
 Reported and interfaced with the nursing specialists and physicians as needed for deficiencies in reported
claims.
 Participated in the ongoing medical record review and disease training program.
February 2009 - February 2010
Clinical Safety Specialist
Novella Clinical - Durham, NC (Aerotek)
 Processed individual case safety reports electronically submitted into the clinical database.
 Performed data entry of safety reports into ARISg5 safety database.
 Determined seriousness of reported events from subject medical records, progress notes, etc.
 Composed comprehensive safety narratives for submission as required by regulatory authorities.
 Generated queries as required to resolve clinical and safety databases.
 Coded medications and adverse experiences with relevant medical dictionaries.
 Liaised with medical monitors to resolve medical issues found in the safety report prior to submission.
 Executed all safety services as outlined in company SOPs, SMP’s and relevant Sponsor contracts
 Trained sites on SAE reporting guidelines
April 2008 - December 2008
Clinical Research Associate
Health Decisions - Durham, NC
 Reduced documentation errors at sites by creating a universal study-schema tool.
 Performed all phases of site visits as needed for multi-center trials traveling up to 75%.
 Recruited study investigators, reviewed contracts, and negotiated study budgets with sites.
 Collaborated with sites to compile investigator review board submission.
 Collected and processed regulatory documents and reviewed informed consent forms.
 Tracked and managed subject enrollment, study supplies, and IP distribution via I.W.R.S.
 Trained study coordinators on protocol procedures and assisted study coordinators with query resolution
 Identified, documented, and resolved source document and regulatory discrepancies.
 Communicated monitoring findings to PI for adherence to ICH guidelines during the trial.
 Presented at Investigator meetings and assisted site staff and PIs with protocol procedures.

4. Gw yndolyn Carver, B.S. (919) 672-5416
June 2007 - April 2008
Clinical Research Associate
Pharmanet - Morrisville, NC
 Performed site selection, site initiation, interim monitoring and close-out visits as needed for multiple
phase oncology clinical protocols.
 Completed source document review, eCRF review, query resolution, drug accountability and review of
regulatory documents.
 Performed feasibility studies and investigator recruitment.
 Assisted project management with site contracts and budgets, where applicable.
 Reviewed informed consent forms, protocols, and other regulatory documents for accuracy.
 Supported the development of clinical management plans.
 Presented protocols, regulatory documents, and study summaries at Investigator Meetings.
 Monitored IND safety report distribution per regulatory guidelines.
May 2006-February 2007
Serious Adverse Events Coordinator
PPD Pharmacovigilance Group - Morrisville, NC
 Evaluated and processed global SAE reports, for investigational and post-marketed drugs.
 Reviewed source documents to assess SAE reportability per regulatory guidelines.
 Identified and elevated diagnoses SUSARS for expedited reporting.
 Coded medical terms and adverse experiences using the appropriate medical dictionaries.
 Composed comprehensive case narratives, submitted queries, and followed up with sites to resolve case
issues.
 Reviewed appropriate investigator brochures or drug labeling to document SUSAR status.
 Performed peer review and QC of SAE reports prior to submission to regulatory authorities.
 Communicated with Medical Monitors to reconcile SAE report content prior to regulatory submission.
May 2005-May 2006
Senior Data Manager (Project Manager)
INC Research, Inc.
Raleigh, NC
 Project Manager for two stand-alone oncology data management protocols; reporting directly to Sponsor.
 Developed and implemented study-specific data project management plans per Sponsor.
 Coordinated and led internal team meetings and teleconferences.
 Responsible for tracking and metrics reporting.
 Defined expectations, roles, and responsibilities of team members through direct supervision and training.
 Delegated data management tasks to team members.
 Led meetings with direct reports to procure project metrics.