Note: The job is a remote job and is open to candidates in USA. Mass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. The Clinical Research Associate will ensure that regulatory requirements for clinical trials are met by working with clinical teams, IRBs, trial sponsors, and federal 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
- In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth.
- We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
- To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.
Company Overview
Company H1B Sponsorship