How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
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.* 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.Performs other duties as assignedComplies with all Wellstar Health System policies, standards of work, and code of conduct.Required Minimum Education:
- Diploma (Nurse) Nursing or Bachelors Nursing-Preferred
Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.
- RN - Reg Nurse (Single State) or RN-COMPACT - RN - Multi-state Compact
- BLS - Basic Life Support or BLS-P - Basic Life Support-Provisional (30 Days) within 30 Days
Additional License(s) and Certification(s):
Required Minimum Experience:
Minimum 5 years of experience as a nurse; Required andHospital experience Preferred andCritical Care experience Preferred andResearch experience PreferredRequired Minimum Skills:
Strong computer skills;good oral and written communication skills;excellent interpersonal and organization skills.
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