Hybrid Clinical Research Associate – Regulatory Trials

Massachusetts General Hospital; Boston (MA); Hybrid; USD 28.000 - 40.000; Vollzeit

Benefits dieser Stelle

Health benefits

Zusammenfassung

Mass General Brigham in Boston is seeking a Clinical Research Associate to ensure regulatory requirements for clinical trials are met. You will work with clinical teams, IRB, sponsors, and federal agencies, and receive training on applicable regulations.

The role emphasizes attention to detail, communication with vendors and staff, and maintaining trial documentation. Hybrid work location at 101 Merrimac Street with competitive pay and benefits.

Qualifikationen

• Bachelor's Degree required.
• 1–2 years research experience preferred.
• Attention to detail.
• Ability to recognize compliance and data integrity issues.
• Working knowledge of clinical research protocols.
• Ability to communicate effectively with patients, vendors, CROs and professional staff.
• Effective interpersonal and communication skills.

Aufgaben

• 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 through 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.

Kenntnisse

Attention to detail

Regulatory compliance

Clinical research protocols

Effective communication

Interpersonal skills

Ausbildung

Bachelor's Degree

Jobbeschreibung

Mass General Brigham in Boston is seeking a Clinical Research Associate to ensure regulatory requirements for clinical trials are met. You will work with clinical teams, IRB, sponsors, and federal agencies, and receive training on applicable regulations.

The role emphasizes attention to detail, communication with vendors and staff, and maintaining trial documentation. Hybrid work location at 101 Merrimac Street with competitive pay and benefits.