Note: The job is a remote job and is open to candidates in USA. Massachusetts General Hospital is a not-for-profit organization dedicated to advancing patient care, research, teaching, and community service. The Clinical Research Associate will ensure regulatory requirements for clinical trials are met, working closely with clinical teams, IRBs, and regulatory agencies.

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

Skills

• Bachelor's Degree in a Related Field of Study required
• Attention to detail
• Ability to recognize compliance and data integrity issues and respond appropriately
• Working knowledge of clinical research protocols
• Ability to communicate effectively with patients, vendors, contract research organizations and professional staff
• Effective interpersonal and communication skills
• Research-Related Experience 1-2 years preferred

Benefits

• Comprehensive benefits
• Career advancement opportunities
• Differentials
• Premiums
• Bonuses as applicable
• Recognition programs designed to celebrate your contributions and support your professional growth

Company Overview

Company H1B Sponsorship