Regulatory Compliance Specialist
7 days ago
West Virginia University Research Corporation is a not-for-profit organization established in 1985 to support research at West Virginia University.
We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff, and students of the University.
What We OfferWe are proud to offer a comprehensive benefits package, including 13 paid holidays, paid time off (PTO), a 403(b) retirement savings plan with a fully vested 3% employee contribution match, and a range of health insurance options.
Our employees also enjoy dependent education scholarships, WVU Perks, and a supportive work environment that values diversity and inclusion.
About the OpportunityWe are seeking a highly skilled Regulatory Coordinator to join our team. This individual will be responsible for completing all regulatory activities associated with active industry and cooperative group sponsored clinical studies.
The successful candidate will have a strong understanding of research ethics and regulations governing human subject clinical trials.
ResponsibilitiesThe Regulatory Coordinator will be responsible for:
- Facilitating new protocol submissions for disease team and protocol review committee reviews and notifying relevant research staff of approvals
- Preparing and submitting new and annual Principal Investigator Worksheets for the NCI CIRB
- Submitting Study Specific Worksheets for new protocols to the NCI CIRB and preparing informed consent forms in accordance with Institutional guidelines
- Submitting new protocols to the WVU IRB for local review and acknowledgement
- Scheduling and assisting in making materials for site initiation visits
- Creating initial delegation and training logs
To be successful in this role, you will need:
- A Bachelor's degree in an allied health discipline or related field
- A minimum of two years of experience in regulatory aspects of industry and government-sponsored clinical trials and investigator-initiated clinical trials
- Research Certification with SOCRA or ACRP preferred or able to obtain within six months of hire
The estimated salary for this position is $60,000 - $80,000 per year, depending on qualifications and experience.
In addition to a competitive salary, we offer a comprehensive benefits package, including health insurance, retirement savings, and paid time off.
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