Job Req ID: 206683
Position Number: 00164526
Employment Type: Full Time
Shift: Variable/On Call
Shift Details: M-F, 1st Shift
Standard Hours: 40.00
Department Name: OPR IRB
Location: Therapeutic Research and Devel
Location Details: 1540 Garden Terrace
Carolinas HealthCare System is Atrium Health. Our mission remains the same: to improve health, elevate hope and advance healing - for all. The name Atrium Health allows us to grow beyond our current walls and geographical borders to impact as many lives as possible and deliver solutions that help communities thrive. For more information, please visit carolinashealthcare.org/AtriumHealth
Develops and manages internal operations and procedures of Institutional Review Board (IRB) and educational activities.
- Plans, coordinates and implements policies and administrative functions in accordance with federal regulations and accrediting agency policies and procedures.
- Supervises, develops, and coordinates the clinical research and education for IRB activities. Oversees the administrative functions.
- Supervises and coordinates the federal regulatory management of research protocols.
- Assists in preparing program evaluation.
- Assists in the review of study files and meeting minutes, and prepares reports.
- Coordinates training for research staff and maintains training database, reviews applications for proposed research, and oversees annual review of Instruction Manual.
- Oversees payment of stipends.
- Ensures IRB compliance with federal regulations, IRB compliance with International Conference on Harmonization (ICH) Good Clinical Practice guidelines, revises informed consents with protocol reviews, and determines their appropriate category of review, assists in the oversight of other hospital departments for regulatory compliance.
- Assists in instructing Investigators and Research Support Staff in IRB, FDA and NIH regulations involving human subject research.
- Reviews research protocols and works with Investigators for needed follow-up actions.
Work requires standing, sitting, lifting, reaching, stooping, bending, pushing and pulling. Must be able to occasionally lift and support the weight of 15 pounds in handling equipment and supplies. Works in an office environment with periods of intense detail and deadline activities. Must be able to manage multiple priorities. Requires long periods of sitting, operating computer keyboard and telephone duties.
Education, Experience and Certifications
Associates Degree required. BSN preferred. Will consider candidate with years of experience. 2-3 years of previous research or research regulatory experience preferred.
At Atrium Health, formerly Carolinas HealthCare System, our patients, communities and teammates are at the center of everything we do. Our commitment to diversity and inclusion allows us to deliver care that is superior in quality and compassion across our network of more than 900 care locations.
As a leading, innovative health system, we promote an environment where differences are valued and integrated into our workforce. Our culture of inclusion and cultural competence allows us to achieve our goals and deliver the best possible experience to patients and the communities we serve.
Posting Notes: Not Applicable
Carolinas HealthCare System is an EOE/AA Employer
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