Responsible for protecting the rights and welfare of research subjects while performing biomedical and social-behavioral research in accordance with Good Clinical Practice, all federal regulatory bodies, and research protocols.
Manages processes effectively in regard to employee/patient safety.
Maintains all required records, reports, statistics, logs, files and other documents as required.
Promotes a culture of process improvement by participating in unit/department based programs that supports the system’s process improvement goals.
Actively participates on system-wide or hospital-based teams as needed.
Role Specific Responsibilities
Recruits and verifies eligibility of study subjects in compliance with the principles of the Belmont Report, Good Clinical Practice, and federal regulations of OHRP and FDA.
Reviews and obtains informed consent and documents process;
Schedules and conducts study visits with subjects;
Conducts follow-up phone calls with subjects ;
Scores test results;
Collects survey data and review medical records
Consults with nurses and physicians to determine subject eligibility according to protocol requirements;
Facilitates communication with and education of investigators, key personnel and subjects to maintain project study flow;
Maintains detailed study records. Performs scientific literature searches in support of research;
Completes research documents in compliance with current local, state, and federal regulatory guidelines, requirements, laws and research protocols.
Participates in outreach to promote clinical research at SIH, including but not limited to outreach to physicians, staff, patients, or community.
Identifies, records, reports and follows Adverse Events (AE) and Serious Adverse Events (SAE). Collaborates with investigator to address AE and SAE resolution.
Identifies and reports protocol deviations, including corrective action plans.
Maintains test article (drug or device) and research supply accountability per protocol and SOP.
Bachelor's degree in a social or health science. Or the equivalent combination of education and experience.
Must complete NIH Protection of Human Research Participants and NUCATS training before interacting with any participants and must complete continuing education annually.
Clinical Research Professional certification within two years of hire.