Dedicated, detail-oriented clinical research coordinator with 15+ years experience looking to make the transition to clinical research associate. Capable of contracting and budgeting, study start-up, and regulatory reporting. Works professionally and closely with sponsor representatives, CRAs, site personnel, and study participants to successfully fulfill site obligations to sponsor.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Synergy Healthcare
10.2022 - Current
Fundamental in the site transition from paper source documents to eSOURCE.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Developed and edited site's eSOURCE documents in RealTime CTMS.
Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
Clinical Research Coordinator/Medical Assistant
Susan H. Weinkle, MD
04.2006 - 11.2022
Completed 26 clinical trials with hundreds of study subjects.
Liaised with sponsor representatives to complete contracting/budgeting, IRB reporting, and site initiation documentation.
Gathered, processed, and shipped lab specimens.
Maintained compliance with protocols covering patient care and clinical trial operations.
Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
Followed informed consent processes and maintained records.
Collected data and followed research protocols, operations manuals, and case report form requirements.
Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Senior biologist/Assistant Manager
Sarasota Bay Explorers, Inc.
02.2002 - 01.2006
Narrated a 1 hr 45 min eco-tour of Sarasota Bay.
Ensured the safety of up to 40 passengers while boarding and debarking.
Deployed and retrieved and otter trawl net.
Educated passengers on the ecology of Sarasota Bay and the wildlife observed.
Developed strong working relationships with staff, fostering a positive work environment.
Collaborated with the management team to develop strategic plans for business growth and improvement.
Enforced company policies consistently while handling disciplinary actions when necessary with fairness and respect.
Promoted teamwork within the workplace by encouraging collaboration among staff members on various tasks
Ensured compliance with all safety regulations by conducting regular inspections of equipment/operations.
Mentored junior staff members in their professional development by offering guidance/support in their assigned roles.
Education
Bachelor of Science in Biology - Marine Biology
The Florida State University
Tallahassee, FL
04.2000
Skills
Documentation Management
Data collection techniques
Informed Consent Process
Regulatory reporting (10 years)
Study protocols
Good Clinical Practices
Subject Retention Strategies
Electronic Data Capture
Clinical Research Ethics
Problem-Solving
Adaptability and Flexibility
Teamwork and Collaboration
Certification
Florida Driver's License
Good Clinical Practices, exp 10/2025
Transporting Dangerous Goods, exp 06/2025
Echosens FibroScan Operator, since 11/2022
Timeline
Clinical Research Coordinator
Synergy Healthcare
10.2022 - Current
Clinical Research Coordinator/Medical Assistant
Susan H. Weinkle, MD
04.2006 - 11.2022
Senior biologist/Assistant Manager
Sarasota Bay Explorers, Inc.
02.2002 - 01.2006
Bachelor of Science in Biology - Marine Biology
The Florida State University
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