What are the responsibilities and job description for the Documentation Specialist position at BRCR Global?
Title: Documentation Specialist
The Documentation Specialist plays a crucial role in the clinical trial process by managing and overseeing the daily regulatory activities and 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.
- Languages: Bilingual (English and Spanish).
- Knowledge of FDA regulatory process for US applicable to healthcare settings.
Skills:
- Attention to details.
- Strong verbal and written communication skills.
- Problem solving.
- Analytical skills.
- Microsoft skills.
Job Type: Full-time
Pay: From $20.00 per hour
Education:
- Bachelor's (Required)
Language:
- Spanish (Required)
Work Location: In person
Salary : $20
