Overview
The research coordinator position is responsible for reviewing clinical trial protocols and identifying potential study participants. The position will work closely with the physician investigators, research nurses and study sponsors to help ensure selection of appropriate studies and timely enrollment of eligible patients, leading to successful completion of clinical trials.
Responsibilities
• Conduct clinical feasibility analysis for each protocol evaluated by the program working with practice and service line managers within UofL Health.
• Coordinate the implementation of clinical research projects acting as primary contact with sponsors, CROs, physician investigators and research nurses.
• Maintain training and apply knowledge of all federal regulations governing human subjects research to ensure compliance in enrollment and follow up of study subjects and required reporting of events, deviations, etc (ie. 45 CFR 46, 21 CFR 50, 56, 312, 812, ICH GCP and HIPAA)
• Participate in specialized training as required per protocols and train other study team members as needed, including travel to investigator meetings if required.
• Complete /monitor the screening and recruitment of subjects for research trials using knowledge of current protocols and inclusion/exclusion criteria to determine subject eligibility. Obtain and review medical/clinic records for major contraindications and participate in the informed consent process.
• Collect, organize, and maintain data and test results for source documentation of all research subjects and complete data entry into electronic data capture systems as required by sponsors.
• Processing research specimens as appropriate, and shipping them to a central laboratory while maintaining applicable IATA training
• Maintain accountability for devices, lab kits/supplies and arranging maintenance and training on use of sponsor-provided equipment.
• Prepare and maintain IRB applications/submissions as needed.
• Other duties as assigned
Qualifications
Education / Accreditation / Licensure (required & preferred):
Bachelor’s degree preferred. Years of experience can be substituted for formal degree. Professional certification through SoCRA or ACRP will be obtained in first year of employment if not already earned.
Experience (required and preferred):
Required: Two years of experience in clinical research coordination. Preferred: Experience in regulatory and IRB process
Job ID 2024-43933 Category Hidden (24394) Job Type Regular
