Clinical Research Activation Coordinator II

Massachusetts General Hospital; Boston (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

A major healthcare provider in Boston is seeking a Clinical Research Activation Coordinator II to support the regulatory requirements for clinical trials. This role requires familiarity with Good Clinical Practice and strong organizational skills to maintain compliance with local and national regulations. The ideal candidate will have a Bachelor's Degree in Healthcare Management and 2-3 years of relevant experience in regulatory affairs. Join us to contribute to essential health research and community service.

Qualifications

• 2-3 years of Regulatory Affairs Experience required.
• Understanding of the clinical trial process.
• Ability to manage multiple projects simultaneously.

Responsibilities

• Monitor and maintain compliance with relevant regulations.
• Prepare and submit necessary regulatory documentation.
• Act as a liaison between research team and regulatory authorities.

Skills

Familiarity with Good Clinical Practice (GCP) guidelines

Strong organizational skills

Excellent written and verbal communication skills

Proficiency in relevant software

Education

Bachelor's Degree in Healthcare Management or related field

Job description

Mass General Brigham relies on a wide range of professionals to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care.

The Clinical Research Activation Coordinator II (CRAC II) works independently under general supervision to ensure the regulatory and operational requirements for clinical trials are met prior to activation. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies.

Job Summary

Works independently 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

• Monitor and maintain compliance with applicable local, national, and international regulations, as well as institutional policies and guidelines related to clinical research.
• Prepare, review, and submit all necessary regulatory documentation required for initiating and conducting clinical trials.
• Facilitate the submission of study protocols and related documents to the Institutional Review Board (IRB) or Ethics Committee, ensuring compliance with ethical and safety considerations for human subjects involved in the research.
• Maintain accurate and up-to-date regulatory documentation, including informed consent forms, protocol amendments, safety reports, and other essential study-related documents.
• Prepare and submit timely and accurate regulatory reports, including adverse event reports and safety updates, as required by regulatory authorities and institutional policies.
• Act as a liaison between the research team, principal investigators, sponsors, and regulatory authorities.
• Provide guidance and training to research staff, investigators, and study team members on regulatory matters, best practices, and changes in regulations that may impact the conduct of clinical research.

Qualifications

Education: Bachelor's Degree in Healthcare Management or related field required.

Experience: 2-3 years of Regulatory Affairs Experience required.

Knowledge, Skills and Abilities:

• Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations.
• Understanding of the clinical trial process and the importance of regulatory compliance in protecting research subjects and ensuring data integrity.
• Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously.
• Excellent written and verbal communication skills.
• Proficiency in using relevant software and electronic systems for regulatory documentation management.
• Ability to interpret the acceptability of data results.

EEO Statement: Mass General Brigham Incorporated 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.