Site: The General Hospital Corporation

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.

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.

Principal Duties and Responsibilities:

The following activation duties will be performed independently under general supervision by the Clinical Research Manager:
· Maintain the priority list of upcoming studies and closely track timelines from receipt of protocol to study activation.
· Conduct Pre-Site Qualification visits with sponsors and complete feasibility questionnaires.
· Complete the Activation Checklist to ensure all involved entities are ready for study enrollment.
· Attend Site Initiation Visits and track all pending items identified during the visit.
· Review protocols to determine operational feasibility of required elements.
The following regulatory duties will be performed independently under general supervision by the Clinical Research Manager:
· Maintain and organize study specific electronic regulatory files
· 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
· 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.
· Ensure appropriate documentation of delegation and training for all study staff members.
The following regulatory duties may be performed independently under general supervision by the Clinical Research Manager:
· Participate in monitoring visits and file all monitoring visit correspondence.
· Submit relevant dose cohort updates to the IRB.
· Submit Data and Safety Monitoring Reports.
· Maintain screening and enrollment logs.
· Route all amendments to relevant reviewers and coordinate completion of all signoffs required for activating amendments.
Skills/Abilities/Competencies Required
· Ability to work independently and as a team member
· Analytical skills and ability to resolve problems
· Ability to interpret acceptability of data results
· Careful attention to detail
· Good organizational and communication skills
· High degree of computer literacy
· Working knowledge of clinical research protocols

Job Summary:

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.

Qualifications:

Education:

Bachelor's Degree Healthcare Management required or Bachelor's 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.

Additional Job Details (if applicable)

Physical Requirements

• Standing Occasionally (3-33%)
• Walking Occasionally (3-33%)
• Sitting Constantly (67-100%)
• Lifting Occasionally (3-33%) 20lbs - 35lbs
• Carrying Occasionally (3-33%) 20lbs - 35lbs
• Pushing Rarely (Less than 2%)
• Pulling Rarely (Less than 2%)
• Climbing Rarely (Less than 2%)
• Balancing Occasionally (3-33%)
• Stooping Occasionally (3-33%)
• Kneeling Rarely (Less than 2%)
• Crouching Rarely (Less than 2%)
• Crawling Rarely (Less than 2%)
• Reaching Occasionally (3-33%)
• Gross Manipulation (Handling) Constantly (67-100%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision
• Far Constantly (67-100%)
• Vision
• Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

Remote Type

Remote

Work Location

101 Merrimac Street

Pay Range

$24.28 - $39.43/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 package. In 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.

EEO Statement:

1200 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. 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 Veteran’s 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 (857)-282-7642.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. 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. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.