Registered Nurse (RN) Research Coordinator (Research Experience) - Kennestone

Wellstar Health System•Marietta, GA

About The Position

The Research Coordinator has general responsibility for managing clinical trials for the Clinical Trials Office of the WellStar Health System. Responsibilities include identifying potential study patients, determining patient eligibility, coordinating and following patients in clinical trials, coordinating therapy initiation and continuation, taking calls about clinical-trial issues, completing and filing required forms, and maintaining records for enrolled patients. The coordinator manages patient involvement throughout clinical trials, conducts trial activities in accordance with Good Clinical Practice, FDA, and Institutional guidelines, and ensures regulatory compliance. The role also supports protocol-specific training, monitoring visits, audits, committee and team meetings, regulatory and billing functions, and other departmental projects and duties as assigned.

Requirements

Nursing diploma required; a bachelor's degree in nursing is preferred.
At least 5 years of experience as a nurse.
Registered Nurse (RN) single-state license or RN multi-state compact license required upon hire.
BLS or BLS-Provisional certification; BLS-Provisional must be obtained within 30 days.
Strong computer skills.
Good oral and written communication skills.
Excellent interpersonal and organizational skills.

Nice To Haves

Hospital experience preferred.
Critical care experience preferred.
Research experience preferred.
Bachelor's degree in nursing preferred.

Responsibilities

Coordinate all facets of patient involvement in clinical trials, including consenting and conducting trial activities in accordance with Good Clinical Practice, FDA, and Institutional guidelines.
Review patient charts for eligibility and enroll patients according to protocol guidelines.
Coordinate protocol-specific scheduling with physicians and office staff; attend patient visits and gather protocol-specific information when required.
Communicate drug doses, protocol requirements, and modifications to physicians and office staff.
Coordinate distribution of protocol-provided drug therapy and ensure investigation product chain-of-custody practices are instituted and documented.
Maintain accurate records and current charts for clinical-trial patients; gather source documentation and submit required documentation within designated time frames.
Document eligibility, treatment, and follow-up requirements; provide accurate research information to physicians and sponsors; and enter patient visits into the clinical-trial database.
Prepare research charts for monitoring visits and audits, and assist with those visits as required.
Follow guidelines and timelines for reporting adverse events and deviations, and maintain current protocols, revisions, amendments, and IRB-approved informed consent forms.
Ensure sponsor-required, trial start-up, and ongoing training is completed; attend Investigator Meetings when required; facilitate ongoing training for team members, including investigators.
Maintain current Human Research Participant Protection and Hazardous Material training.
Assist with departmental functions, attend required committee and functional team meetings, disseminate information, and assist with regulatory and billing functions when required.
Complete additional projects as directed by the manager and perform other duties as assigned.
Comply with Wellstar Health System policies, standards of work, and code of conduct.