Clinical Research Associate

Mass General Brigham is a not-for-profit healthcare organization supporting patient care, research, teaching, and community service. The Clinical Research Associate ensures that clinical trial regulatory requirements are met by managing regulatory documentation, submitting materials to institutional and federal entities, and coordinating with clinical teams, IRBs, sponsors, 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

Preferred

Research-Related Experience 1-2 years

Research Experience

Benefits

Hybrid work arrangement

The Clinical Research Associate will be trained on the institutional and federal regulations governing clinical research.

Comprehensive benefits

Career advancement opportunities

Differentials

Premiums

Bonuses as applicable

Recognition programs designed to celebrate your contributions and support your professional growth

Company

Integrated academic healthcare system and biomedical research organization

Somerville, Massachusetts, USA

https://www.massgeneralbrigham.org/

Founded in 1994

10001+ employees

Qualifications

Bachelor's Degree in a Related Field of Study

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

Required skills

Represents the skills you have, click on the tags, Clinical Trial Regulatory Compliance, Institutional Review Board (IRB) Submissions

Preferred skills

Research-Related Experience 1-2 years

Experience

1-2 years