Job Req ID: 196956
Position Number: 00168144
Employment Type: Full Time
Shift: Variable/On Call
Shift Details: 8AM - 5PM M-F
Standard Hours: 40.00
Department Name: LCI Clinical Trials
Location: Carolinas Medical Center
Location Details: Remote
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
Performs study-specific regulatory processes and compliance documentation for oncology research in adherence to industry standards and applicable regulations including FDA/OHRP guidance, ICH/GCP, IRB, and institutional policies.
Highlights of Essential Functions
- Coordinates regulatory documentation associated with oncology research to be reviewed by regulatory bodies such as the IRB and FDA.
- Prepares, reviews, and submits protocol and supporting documents from study start-up through study termination, including amendments, safety reports, renewals, etc.
- Participates in the research start-up activity, working with multiple stakeholders to meet activation timelines.
- Maintains and assures all assigned study regulatory obligations are managed compliantly and timely
- Maintains documentation for assigned studies in an audit-ready manner and assists in the preparation of site audits/inspections.
- Meets with monitors from study sponsored entities and represents Regulatory Affairs during these meetings
- Works closely with the research team and investigators to assure that all regulatory documents for the research studies are up-to-date.
- Serves as the primary study liaison to the IRB of record
- Establishes and maintains research files, including records management and data repositories, pertaining to regulatory and institutional requirements for research trials.
- Assists in the monitoring of clinical trial compliance by reporting issues and problems appropriately.
- Communicates with the research team, sponsors, and IRB on the status of assigned studies
Primarily works in a home-based office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to work remote, be mobile within the entire healthcare system and other locations that participate in LCI research and be on-site at least one day a week or as needed.
Education, Experience and Certifications
Bachelor's Degree and 1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or Master's Degree and 0-1 year of clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required; or a minimum of 3 years clinical research experience with a pharmaceutical company or Contract Research Organization (CRO) or equivalent experience required with no degree. Health/Science degree preferred. Previous experience in a healthcare setting preferred, especially cancer care and/or clinical research. Certification in clinical research (SoCRA, ACRP, RAPS, etc.) 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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