healthcare
Posted YesterdayClinical Research Coordinator II - Hermitage, TN
Hermitage, United StatesOn-site
Responsibilities
- Manage a full schedule of complex study visits and corresponding tasks with minimal direction.
- Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies, with accountability for achieving enrollment goals
- Schedule all patient research visits and procedures consistent with protocol requirements
- Conduct patient visits as outlined within each study protocol
- Perform blood draws, process and ship specimens per study protocol and IATA regulations
- Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
- Maintain high quality data entry within established timelines
- Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager, central Iterative Health team, and PI throughout the study.
- Resolve routine sponsor and CRO issues independently
- Ensure all safety data is reviewed by the PI in a timely manner
- Maintain inventory of study equipment and supplies onsite at all times
- Schedule and prepare for monitor visits
- Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
- Perform quality work within deadlines with or without direct supervision
Requirements
- By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
- Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
- IBD experience is a must
- Ability to own issues and problem solve independently •
- Experience in phlebotomy preferred
- Ability to read, interpret, and apply clinic policies and research protocols