SRI seeks a temp hourly Medical Assistant to support the conduct of clinical trials (Phase I through IV) in our Clinical Trial Unit (CTU) in Plymouth, MI. This medical professional will collaborate with SRI’s medical and operational personnel to perform study-related patient care as well as administrative tasks such as completing medical/study documentation, data entry, and attending meetings. Patient care of study participants will be performed primarily at the Unit. The incumbent will perform patient care tasks and/or study procedures in alignment with applicable MI scope of practice for his/her credentials. The individual should be able to work well within a team and have schedule flexibility to work night and/or weekend shifts as needed. This role is part-time hourly, and we anticipate 10-24 hours per week, mostly overnights.
- Works with the Director, Site Manager, Nurses, and others in conducting clinical research on new drugs, vaccines, medical devices, diagnostics, or other materials.
- Protects the rights, safety and welfare of study participants.
- Conducts clinical trials according to appropriate FDA, ICH or other guidelines, under the supervision of the SRI CTU management and study Principal Investigator.
- Assist with study coordination and the collection of data, including timely data entry into study specific paper and/or electronic Case Report Forms (CRFs).
- Assist with pre-study, study and post-study physical examinations, specimen, EKG and vital sign collection.
- Support medical staff with 24-hour coverage when overnight, inpatient studies are being conducted.
- Assists medical staff with treatment for medical emergencies.
- Safeguard and monitor study participant safety at all times.
- Maintains safe and clean working environment by complying with procedures, rules, and regulations; protects study participants and employees by adhering to infection-control policies and protocols, medication administration and storage procedures, and controlled substance regulations.
- Document study participant care services by charting in study records.
- Maintain study participant confidence and protect operations by keeping information confidential.
- Assist with upkeep of facilities and equipment by completing preventive maintenance requirements; following manufacturer's instructions; troubleshooting malfunctions; notifying Supervisor/Management to call for repairs and providing updates regarding equipment inventories; and evaluating new equipment and techniques.
- Help maintain medical supply inventory monitoring inventory levels/expirations; anticipating needed supplies; and using equipment and supplies as needed to accomplish job results.
- Maintain professional and technical knowledge by staying current with recommended learning events/workshops/virtual sessions.
- Certified Medical Assistant.
- 3-5 years of experience as a practicing MA.
- Current BLS certification.
- No prior sanctions by a state licensing agency; not disqualified from or restricted in the participation of clinical research by the FDA.
- Strong interpersonal and leadership skill, self-motivation and high personal integrity and ethics.
- Strong computer skills, MS Word and Excel for data collection and analysis.
- At least 1 year clinical research experience is a plus.