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Description
Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve.
Summary:
The primary purpose of this position is to ensure our site’s compliance in conducting clinical research in all our facilities.
Responsibilities:
1.Independently administer regulatory compliance for assigned studies, applying full knowledge of Good Clinical Practice (GCP) and the federal regulations governing clinical research in the United States.
2.Take responsibility for IRB submissions and modifications (accurate & timely preparation for initial reviews, amendments, annual renewals and ad hoc submissions).
3.Provide appropriate training and compliance guidance to our investigators, research staff and other key personnel during our study start up meetings and during the ongoing conduct of each research study.
4. Lead multiple concurrent study projects and negotiate sharing of work within the regulatory team to accomplish research objectives. Schedule and direct activities effectively; make changes to workflow and assignments in consultation with research manager.
5. Lead exchange of information with sponsors, auditors, investigators and IRBs; collaborate as needed to resolve key regulatory issues efficiently.
6. Conduct root cause analysis in collaboration with research manager to determine course of events leading to any protocol deficiency/deviation/violation. Guide staff in proper documentation of clarifying notes for study specific regulatory files and develop written corrective and preventive actions (CAPAs) as required.
7. Maintain essential documents for all investigators and study files. Ensure all key personnel have documented training for each study. Take responsibility for maintaining each study’s delegation of authority and training log documents.
8. Create and maintain professional working relationships with investigators, sponsors, team members, IRB personnel.
9. Provide consultation and guidance to our Regulatory Specialist on IRB processes, implementation of IRB actions and regulatory compliance.
10. Write comprehensive reports that convey meaning effectively.
11. Lead all audit preparations for our regulatory team. Be prepared to speak authoritatively during any scheduled or unscheduled audit.
Legal Employer: NCHEALTH
Entity: UNC REX Healthcare
Organization Unit: Rex Cancer Center Research
Work Type: Full Time
Standard Hours Per Week: 40.00
Salary Range: $25.94 - $37.29 per hour (Hiring Range)
Pay offers are determined by experience and internal equity
Work Assignment Type: Hybrid
Work Schedule: Day Job
Location of Job: US:NC:Raleigh
Exempt From Overtime: Exempt: Yes
This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Heath Care System. This is not a State employed position.
Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email applicant.accommodations@unchealth.unc.edu if you need a reasonable accommodation to search and/or to apply for a career opportunity.
Full Time
Hospital
$101k-134k (estimate)
04/06/2024
07/02/2024
www.unchealthcare.org
Morrisville, North Carolina
15,000 - 50,000
Tom Murray
<$5M
Hospital
The UNC Health Care System is a not-for-profit integrated health care system, founded in 1998, owned by the State of North Carolina and based in Chapel Hill. It exists to further the teaching mission of the University of North Carolina and to provide state-of-the-art patient care. A distinguishing characteristic of UNC Health Care is its association with the UNC-Chapel Hill School of Medicine, a nationally eminent research institution. This relationship gives UNC Health Care a powerful pathway for moving the results of biomedical research from medical school laboratories to patient care settin...gs. UNC Health Care has been granted broad powers by the North Carolina General Assembly to assure its management flexibility and competitiveness in a rapidly changing health care business environment. The enterprise is governed by a board of directors appointed by the University of North Carolina.
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The following is the career advancement route for Regulatory Associate positions, which can be used as a reference in future career path planning. As a Regulatory Associate, it can be promoted into senior positions as a Top Regulatory Affairs Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Associate. You can explore the career advancement for a Regulatory Associate below and select your interested title to get hiring information.