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Regulatory Affairs Specialist

Company: 3Sync Research
Location: Fort Lauderdale
Posted on: November 26, 2022

Job Description:


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

* Dental insurance
* Health insurance
* Paid time off
* Vision insurance
* 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)

* English & Spanish (Required)

Work Location: One location%58047475%

Keywords: 3Sync Research, Fort Lauderdale , Regulatory Affairs Specialist, Other , Fort Lauderdale, Florida

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