The Clinical Research Coordinator works closely with study subjects and other research staff and is responsible for the day-to-day clinical research process to collect, compile, document, and analyze clinical research data. Working under direct supervision, the position assists the investigator with subject follow-up visits, completes clinical tasks, prepares research documentation, reports, and graphs while keeping appropriate logs, tracking participants, and preparing study materials.
Essential Job Function:
- Assesses patients for protocol eligibility, ensuring the appropriate selection of participants for clinical trials, thereby enhancing the accuracy and validity of research outcomes.
- Confers with study participants to explain the purpose of the study and obtains informed consent, fostering transparency and trust with patients and their families throughout the research process.
- Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data.
- When applicable, completes documentation in the electronic health/medical record (EMR) system to securely maintain patient health records.
- Coordinates multiple, less complex clinical trials simultaneously, managing and organizing various research activities efficiently, and ensuring optimal use of resources and timely execution of research protocols.
- Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements.
- Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital.
- Completes clinical tasks (i.e., electrocardiogram (ECG), pulmonary function tests (PFT), phlebotomy, drug administration, etc.) when not prohibited by state or licensing board requirements under the supervision of the principal investigator.
- Performs other duties as assigned.
Education:
- Required: Bachelor's Degree or Associate's Degree (with 2 yrs experience) or Healthcare/Health-related certification, e.g., EMT, Pharm Tech, Rad Tech, etc. (with 4 yrs experience).
Experience:
- Required: 4 Years (education and/or experience).
Licensure/Certification/Listing:
- Preferred: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification.