Clinical Research Coordinator

CCHC Pulmonary and Sleep Medicine The Clinical Research Coordinator will be responsible for the start-up, implementation, and on-going coordination of clinical research studies conducted at Coastal Carolina Health Care, P.A. (CCHC). The primary location of the clinical research department is located at CCHC Pulmonary and Sleep Medicine. We will soon be conducting research at our CCHC New Bern Internal Medicine Specialists location in the neurology department. The candidate will work with physicians conducting research (Investigators) and other members of a well-established clinical research team to lead day-to-day operations of clinical research. The candidate's responsibilities will include all activities from study start-up to study closure. The position is full-time, 40 hours per week.

Duties Include:

Completion of start-up and regulatory documents Institutional Review Board (IRB) submission and ongoing communications (i.e. continuing review, adverse event reporting, etc.) Prescreening medical records for identification of potential study participants Obtaining informed consent of study participants Serving as primary contact with research participants, sponsors, and regulatory agencies Scheduling, coordination, and conduct of sponsor monitoring visits and regulatory audits Completion of protocol-specific procedures, including the collection, processing, and shipping of specimens Completion of study visits, collection and documentation of study data; data entry into electronic data capture (EDC) systems Development of study related documents Management of protocol-specific supplies Ensuring compliance with protocols, regulations, and site standard operating procedures (SOPs) Frequent interaction with the Principal Investigator and delegated study team to ensure patient safety and adherence to proper study conduct Other duties will be assigned

Desired Professional Skills and Experience:

Previous clinical research experience is preferred CMA, LPN, or RN preferred; unlicensed professionals with clinical research experience may be considered Knowledge of or training in Good Clinical Practice (GCP) guidelines preferred; the candidate will be required to complete GCP training and other trainings Excellent communications and organizational skills Independence, multitasking, and attention to detail Experience in

Microsoft Word and Excel Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off

Work Location:

In person