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Job Summary:\rThe 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.\rCore Responsibilities and Essential Functions:\rCoordinates all facets of patient involvement in clinical trials.\r* Conducts all aspects of clinical trial, including consenting, using Good Clinical Practice, FDA, and Institutional guidelines.\r* Reviews patient chart for eligibility requirements and enrolls patient according to protocol guidelines.\r* Communicates with physician/office staff regarding scheduling protocol specific requirements.\r* Attends patient visits and gathers protocol-specific information when required.\r* Communicates drug doses, protocol requirements and modifications to physician and office staff as appropriate.\r* Coordinates dispersement of protocol provided drug therapy.\r* Ensures that Investigation Product chain-of-custody practices are instituted and documented.\rMaintains accurate records for patients enrolled on clinical trials.\r* Communicates effectively with Research Assistants and other research staff.\r* Gathers appropriate source documentation\r* Submits required documentation within designated time frame.\r* Provides proper documentation of eligibility, treatment and follow-up requirements.\r* Provides accurate research information to physicians and sponsors.\r* Maintains a current chart on each protocol patient.\r* Enters patient visits into clinical trial database.\rEnsures regulatory guidelines are followed.\r* Prepares research charts for monitoring visits and audits and assists with visits as required.\r* Follows guidelines and timelines for reporting Adverse Events and Deviations.\r* Maintains current protocol with revisions, amendments and current IRB approved informed consent.\rEnsures clinical trial and sponsor-required training is completed.\r* Ensures that all training related to start-up of a clinical trial is accomplished, including attending Investigator Meetings when required.\r* Ensures that ongoing training during the course of a clinical trial is completed.\r* Facilitates ongoing training for other team members, including investigators.\r* Maintains current Human Research Participant Protection and Hazardous Material training.\rAssists with other departmental functions.\r* Attends committee meetings as required.\r* Attends functional team meetings and disseminates information.\r* Assists with regulatory and billing functions, when required.\r* Responsible for additional projects, as directed by the manager.\rPerforms other duties as assigned\rComplies with all Wellstar Health System policies, standards of work, and code of conduct.\rRequired Minimum Education:Diploma (Nurse) Nursing or Bachelors Nursing-Preferred\r\rRequired Minimum License(s) and Certification(s):\rAll certifications are required upon hire unless otherwise stated.RN - Reg Nurse (Single State) or RN-COMPACT - RN - Multi-state CompactBLS - Basic Life Support or BLS-P - Basic Life Support-Provisional (30 Days) within 30 Days\rAdditional License(s) and Certification(s):\rRequired Minimum Experience:\rMinimum 5 years of experience as a nurse; Required and\rHospital experience Preferred and\rCritical Care experience Preferred and\rResearch experience Preferred\rRequired Minimum Skills:\rStrong computer skills;\rgood oral and written communication skills;\rexcellent interpersonal and organization skills.

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