Clinical Research Associate

The role involves ensuring regulatory compliance for clinical trials, working with clinical teams, IRB, sponsors, and federal agencies. It requires maintaining documentation, preparing reports, and managing regulatory submissions.

Location: 55 Fruit Street

Salary: $20.16 - $29.01/Hourly

Responsibilities

• Maintain and organize study-specific regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents to include new risk information and/or updated protocol requirements throughout the course of the study.
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.
• Collect, complete, and submit essential regulatory documents to various regulatory entities.
• Participate in monitoring visits and maintain a record of all correspondence related to these visits.

Requirements

• Bachelor's Degree in a Related Field of Study required.
• Research-Related Experience 1-2 years preferred.

Benefits

• Comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses, recognition programs.

Additional Information

• Remote work type.