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Work Shift

Job Summary:

The Research Coordinator has general responsibility for managing clinical trials for the Clinical Trials Office of the WellStar Health System. This includes responsibility for identifying potential study patients; ascertaining patient eligibility for clinical trials; coordinating, evaluating, and following patients in clinical trials; coordinating therapy initiation and continuation; taking call for issues related to clinical trials; completing and filing necessary forms with internal and external departments and agencies as necessary; and maintaining records for patients enrolled in clinical trials.

Core Responsibilities and Essential Functions:

Coordinates all facets of patient involvement in clinical trials.
- Conducts all aspects of clinical trial, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines.
- Reviews patient chart for eligibility requirements and enrolls patient according to protocol guidelines.
- Communicates with physician/office staff regarding scheduling protocol specific requirements.
- Attends patient visits and gathers protocol-specific information when required.
- Communicates drug doses, protocol requirements and modifications to physician and office staff as appropriate.
- Coordinates dispersement of protocol provided drug therapy.
- Ensures that Investigation Product chain-of-custody practices are instituted and documented. Maintains accurate records for patients enrolled on clinical trials.
- Communicates effectively with Research Assistants and other research staff.
- Gathers appropriate source documentation
- Submits required documentation within designated time frame.
- Provides proper documentation of eligibility, treatment and follow-up requirements.
- Provides accurate research information to physicians and sponsors.
- Maintains a current chart on each protocol patient.
- Enters patient visits into clinical trial database. Ensures regulatory guidelines are followed.
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Prepares research charts for monitoring visits and audits and assists with visits as required.
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Follows guidelines and timelines for reporting Adverse Events and Deviations.
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Maintains current protocol with revisions, amendments and current IRB approved informed consent. Ensures clinical trial and sponsor-required training is completed.
- Ensures that all training related to start-up of a clinical trial is accomplished, including attending Investigator Meetings when required.
- Ensures that ongoing training during the course of a clinical trial is completed.
- Facilitates ongoing training for other team members, including investigators.
- Maintains current Human Research Participant Protection and Hazardous Material training. Assists with other departmental functions.
- Attends committee meetings as required.
- Attends functional team meetings and disseminates information.
- Assists with regulatory and billing functions, when required.
- Responsible for additional projects, as directed by the manager.

Required Minimum Education:

Graduate from an approved school of nursing. Required and
Bachelor's Degree BSN Preferred

Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.

• Reg Nurse (Single State) or RN - Multi-state Compact

Additional License(s) and Certification(s):



Required Minimum Experience:
Minimum 5 years RN experience Required and
Minimum 2 years Research experience

Hospital experience

Critical Care experience

Required Minimum Skills:
Strong computer skills;
good oral and written communication skills;
excellent interpersonal and organization skills.

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