Clinical Research Activation Coordinator II

Site: Mass General Brigham Incorporated

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

General Summary/Overview Statement:


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 may also involve post-activation regulatory responsibilities. This position involves working with clinical teams Institutional Review Boards (IRB) clinical trial sponsors and federal regulatory agencies. The CRAC II will be trained on the institutional and federal regulations governing clinical research. This position does not include any direct patient contact.


Working Conditions
Duties will be performed remotely

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. Will be trained on the institutional and federal regulations governing clinical research. This position does not include any direct patient contact.

Does this position require Patient Care No

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.

Education
Bachelors Degree Healthcare Management required or Bachelors Degree Related Field of Study required

Can this role accept experience in lieu of a degree No

Licenses and Credentials

Experience
Regulatory Affairs Experience 2-3 years required

Knowledge Skills and Abilities
- Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations (e.g. ICH E6 21 CFR etc.).
- 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.

Remote

101 Merrimac Street

40

Regular

Day (United States of America)

Pay Range

$23.80 - $34.81/Hourly

Grade

6

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. The base pay information provided offers an estimate based on the minimum job qualifications; however it does not encompass all elements contributing to your total compensation 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 invite you to apply and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

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. 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 Veterans 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 .

Mass General Brigham Competency Framework