Adverse Events, Billing, Clinical Data, Clinical Trial, Clinical Trial Management, Communication Skills, Drug Therapy, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Hazardous Materials/Substances, Healthcare, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Interpersonal Skills, Medical Office, Organizational Skills, Patient Assessment, Patient Charts, Patient Follow-up, Presentation/Verbal Skills, Record Keeping, Registered Nurse (RN), Regulations, Startup, System Integration (SI), Writing Skills
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
Day (United States of America)
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):
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.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
W
WellStar Health System Inc
As the largest healthcare system in the suburbs of Atlanta, WellStar serves more than a million patients a year within our hospitals, health parks, urgent care centers, and medical practices in NW Atlanta. We are a leading not-for-profit health system with state-of-the-art medical technology and a world-class employee family. Onsite concierge services, pension plans and job sharing are just the start of our innovative vision of a ‘Work Life Well Lived!’
10,000 employees or more
http://www.wellstarcareers.org/index.asp