The Regulatory Assistant 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.

Languages:

Bilingual (English and Spanish).

Skills:

Attention to details. Strong verbal and written communication skills. Problem solving. Analytical skills. Microsoft skills.

Job Type:

Full-time Benefits:

401(k) Health insurance Paid time off

Language:

Spanish (Required)

Work Location:

In person