What are the responsibilities and job description for the Regulatory Affairs Specialist position at BRCR Global?
The Regulatory Affairs Specialist plays a crucial role in the clinical trial process by giving support and overseeing the daily regulatory activities by ensuring compliance with relevant regulations.
Principal Responsabilities:
- Prepare and maintain complete and accurate regulatory documents in support of clinical research studies.
- Manage all the communication with the IRB and Sponsor.
- Prepare each study-specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB.
- Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB-required submissions.
- Work with staff members to complete Financial Disclosure Forms for each study.
- Assist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as needed.
- Maintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to always ensure audit readiness.
- Assist site leadership and coordinators in the preparation for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binder.
- Assist with the preparation and submission of closeout documents to the sponsors and IRBs including ensuring completeness, audit-readiness, and closure of the regulatory binder and appropriate archival of trial data.
- Submit or support SAE and AE submissions to the IRB as needed and in a timely fashion
Job requirements:
- Education: Bachelor's degree in Science or related fields.
- Experience: 1 year of experience in Regulatory Affairs for Clinical Research.
- Languages: Bilingual (English and Spanish).
Skills:
- Attention to details.
- Strong verbal and written communication skills.
- Problem solving.
- Analytical skills.
- Microsoft skills.
Pay: $23.00 - $26.00 per hour
Expected hours: 40.0 per week
Benefits:
- 401(k)
- Paid time off
Experience:
- Regulatory Affairs : 1 year (Preferred)
Language:
- English (Preferred)
- Spanish (Preferred)
Work Location: In person
Salary : $23 - $26