SARAH SELLERS
Yukon,Oklahoma
Summary
Diligent Clinical Research Associate with robust background in clinical research and trial monitoring. Successfully managed multiple studies, ensuring compliance with protocols and regulatory requirements. Demonstrated proficiency in data analysis and participant coordination, contributing to high-quality research outcomes.
Overview
5
5
years of professional experience
Work History
Clinical Research Associate
Agendia
06.2024 - Current
- Managed and coordinated 21 clinical research sites, ensuring seamless operation, adherence to study protocol, regulatory compliance, and timely data collection across multiple phases of research trials.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted 5 initiation, 18 monitoring and 2 closeout visits to verify study procedures, regulatory documents and data completion.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Negotiated contracts with investigational sites on behalf of sponsors, securing favorable terms while adhering to budgetary constraints.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
Clinical Research Associate
Nordic Bioscience Clinical Development
01.2023 - 05.2024
- Led and managed 26 research sites across 3 protocols coast-to-coast domestically while coordinating with an international team of approximately 350 employees throughout the conduct of 3 studies
- Executed approximately 60 clinical research study visits including 38 Monitoring Visits, 15 Site Initiation Visits, 3 Site Qualification Visits, 12 co-visits to instruct and lead new CRA's and 5 Close Out Visits
- Performed source data verification and source data review for approximately 25,000-30,000 data points to ensure data integrity
- Mastered understanding of study protocols, lab manuals, pharmacy manuals, and several other documents for 3 different studies
- Trained and supervised research site personnel on study procedures, drug administration, and data collection needs
- Structured meticulous records for internal and regulatory needs
- Produced detailed reports to present to Study Management members
Severe Adverse Events Team Lead/Manager: Early and Late Phase Clinical Trials
Stephenson Cancer Center
05.2022 - 12.2022
- Structured Severe Adverse Event reports to sponsors/PV/safety agencies
- Participated in the Management Training Program at Stephenson Cancer Center
- Leads SAE team for all Early Phase and Late Phase studies with 3 direct reports while overseeing daily operations of team, ensuring timely completion of tasks and projects
- Collaborated with Principal Investigators, Sub-Investigators, and study staff to report SAE's within the required 24 hours
- Examined patient files, study data, and medical records to gather reportable information and review patient safety
- Updated multiple Data Capture Systems to ensure information is reported to the proper authorities
Research Program Coordinator: Early Phase Clinical Trials
Stephenson Cancer Center
10.2020 - 05.2022
- Maintained data and patient care for approximately 30 Phase 1 Oncology Clinical Trials
- Collaborated with academic and clinical staff to streamline clinical research processes and envision improvements within the department
- Demonstrated mastery of clinical protocols, laboratory manuals, informed consent documents, and other study-related materials
- Assisted clinical investigators in planning, organizing, and delivering management of study documents
- Directed training and education to the Stephenson Cancer Center staff, Faculty, and external sites' research staff concerning the research projects and Phase 1 Program
Oncology Research Coordinator
Stephenson Cancer Center
01.2020 - 10.2020
- Conducted data collection and discrepancy reconciliation in EDC
- Acted as the initial clinical resource and liaison between physicians, nurses, and laboratory personnel
- Collected data for active patients and patients in longitudinal follow-up
- Liaised communication with monitors/sponsors and site staff to eliminate queries and answer safety questions
- Performed data entry ensuring accuracy and timeliness of reporting
- Initiated, organized, and handled of patient follow-up
- Assessed and analyzed patient monitor data at all follow-up visits
- Ensure adherence to protocol
- Maintained meticulous records for internal and regulatory needs, including drug dispensation and case report forms
Education
Bachelor of Science (B.Sc.) - Health and Exercise Science
University of Oklahoma
05.2018
Skills
- Clinical Trial Management
- Site Management
- Study Start Up
- Quality Assurance
- Drug Accountability
- Study Closure
- Interpersonal Skills
- Clinical Study Reports
- Electronic data capture
- Pharmacovigilance
Timeline
Clinical Research Associate
Agendia
06.2024 - Current
Clinical Research Associate
Nordic Bioscience Clinical Development
01.2023 - 05.2024
Severe Adverse Events Team Lead/Manager: Early and Late Phase Clinical Trials
Stephenson Cancer Center
05.2022 - 12.2022
Research Program Coordinator: Early Phase Clinical Trials
Stephenson Cancer Center
10.2020 - 05.2022
Oncology Research Coordinator
Stephenson Cancer Center
01.2020 - 10.2020
Bachelor of Science (B.Sc.) - Health and Exercise Science
University of Oklahoma
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