Regulatory Affairs Specialist (Clinical Research)
Job description
Responsibilities
Prepare and maintain complete and accurate regulatory documents in support of clinical research studies
Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB
Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up
Ensures regulatory submissions are done in a timely manner as to not delay study start up
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 new hires in completing and submitting all required research documentation and trainings by their deadlines
Assist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as needed
Assist coordinators in ensuring that all staff on the delegation of authority logs have the appropriate training on file
Maintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to ensure audit readiness at all times.
Notify staff and Site Manager/Director of upcoming training expiration dates
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
Supports maintenance oof DOA logs and any other required logs as needed
Submit or support SAE and AE submissions to the IRB as needed and in a timely fashion
Supports audit and inspection readiness by ensuring accurate and timely file completion
Provide copies of IRB documents to sponsors, as needed
Adhere to safety and compliance regulations
Job Type: Full-time
Pay: $80,000.00 - $95,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
- Weekend availability
Supplemental pay types:
- Bonus pay
Ability to commute/relocate:
- Fort Lauderdale, FL 33309: Reliably commute or planning to relocate before starting work (Required)
Language:
- English & Spanish (Preferred)
Work Location: In person
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