Clinical Trial Research Coordinator Inspire health. Serve with compassion. Be the difference. Responsible for the implementation and day-to-day management of clinical trial research studies, including educating research staff, health care team members, participants, and caregivers. Coordinates the collection, submission, and oversight of clinical data; monitors protocol compliance; and maintains systems to support accurate and timely data flow. Manages participant visits and carries out protocol required procedures. Monitors participant progress and safety, and communicates relevant updates to investigators, regulatory offices, the health care team, and study staff.
Essential Functions:
Manages study operations by coordinating day today study operations and developing strategies to contribute to the program growth. Monitors study progress and maintains compliance with protocols and regulations Supports investigator-initiated studies by assisting with protocol development, literature reviews, and creation of data collection tools. Coordinates industry sponsored clinical trials by implementing sponsor provided protocols, completing required regulatory submissions, and ensuring adherence to study procedures and timelines. Assists in coordinating resources to conduct trials including the development of data collection tools and communication with ancillary departments to implement study related procedures. Collaborates with Research Services offices and sponsoring or local agencies to submit required study documents and ensure awareness of study progress, amendments, and regulatory activities. Performs other duties as assigned.
Supervisory/Management Responsibilities:
This is a non-management job that will report to a supervisor, manager, director or executive.
Minimum Requirements
Education: Bachelor's Degree in Health Sciences or Business-related field of study.
Experience:
Two (2) years of research experience in at least one of the following areas: pharmaceutical, academic, device, National Institute of Health (NIH), investigator-initiated studies or registry trials. In Lieu OfIn lieu of education and experience noted above an equivalent combination of work experience and academic experience may be considered. Required Certifications, Registrations, LicensesBLS is required within six (6) months of employment. Collaborative Institutional Training Initiative (CITI) preferred. If Allied Health Degree: State certification/license in field. Some team members may be required to have a valid driver's license to perform the essential functions of the role. In these situations, an acceptable motor vehicle record as defined by the Acceptable Motor Vehicle Record (MVR) Chart, and proof of auto insurance is required.
Knowledge, Skills and Abilities:- Ability to apply Good Clinical Practice (GCP) principles independently across studies
- Knowledge of clinical research regulations to daily operations
- Ability to apply protocol requirements and troubleshoot visit issues
- Ability to effectively use specialty-specific terminology
- Ability to independently interpret medical records with minimal assistance
- Ability to independently manage quality data abstraction and ensure high-quality source documentation standards
Ability to maintain ongoing professional development by participating in seminars, workshops, in-service trainings, and by staying current with relevant literature and emerging trends in the field.
Work ShiftDay (United States of America)
Location
Cancer Centers - Faris Road
Facility1008 Greenville Memorial Hospital
Department10559220 OP Oncology Research-CIF
