Facility: Kennestone Hospital

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. - Prepares research charts for monitoring visits and audits and assists with visits as required. - Follows guidelines and timelines for reporting Adverse Events and Deviations. - 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):

Reg Nurse (Single State) 1.00 Required RN - Multi-state Compact 1.00 Required

Additional Licenses and Certifications:

Required Minimum Experience:

Minimum 5 years of experience as a nurse; Required and Hospital experience Preferred and Critical Care experience Preferred and Research experience Preferred

Required Minimum Skills:

Strong computer skills; good oral and written communication skills; excellent interpersonal and organization skills.