Clinical Research Associate

Job Summary

Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies.

Essential Functions

• Maintain and organize study-specific regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Rewrite 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.

Qualifications

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

Knowledge, Skills And Abilities

• 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.

Additional Job Details (if Applicable)

• Remote Work Location: 55 Fruit Street.
• Pay Range: $20.16 - $29.01/Hourly.
• Grade: 5.

At Mass General Brigham

• We believe in recognizing and rewarding the unique value each team member brings to our organization.
• Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors.
• 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.

EEO Statement

The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law.

Mass General Brigham Competency Framework

• The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success.