McLaren Health Care
Location
Flint, Michigan
Facilitates clinical research studies by evaluating candidate eligibility and managing the informed consent process. Coordinates study procedures, collects data, and ensures compliance with research protocols and regulatory requirements.
Requires a high school diploma and either two years of clinical research experience or five years in a healthcare role. A degree in biology or psychology and SOCRA/ACRP certification are preferred.
Responsible for facilitating research studies; providing knowledgeable information regarding each research protocol to the medical and nursing staff; evaluating the eligibility of potential candidates for research studies; assisting in the informed consent process; monitoring research study compliance; collecting and submitting data; coordinating required study procedures to meet protocol requirements and maintain a system for effective data flow. Essential Functions and Responsibilities: 1. Evaluates eligibility of candidates for clinical research studies by reviewing protocol defined eligibility requirements and/or collecting pertinent data on potential candidates, verifying appropriateness of patients for entry to clinical trials, and assisting the other staff in determining eligibility of potential patients. 2. Assists the investigator with the informed consent process and assures that the research team and the patient have adequate information to achieve the informed consent process. 3. Registers and randomizes eligible patients. 4. Submits accurately completed data collection forms to the sponsor or CRO in a timely manner as dictated by the study protocol. 5. Coordinates tests and procedures as specified in the study protocol through accurate communication with the site / principal investigator, physicians, patients, nurses, and office/hospital staff. 6. Maintains contact with regulatory specialist to ensure data submitted to the IRB of record is accurate and timely. Upon request, submits regulatory documents to regulatory specialist to include in the IRB submission or submission to sponsor or CRO. 7. Assists the investigators and clinicians in identifying and enrolling eligible patients into clinical trials/ studies and assures compliance to protocol requirements. 8. Educates patients and their families regarding research protocols and keeps them informed of procedures and changes in the studies in which they are participating.
