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.

The Clinical Research Regulatory Coordinator I (CRRCI) 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. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.

Principal Duties and Responsibilities:

The following regulatory duties will be performed under general supervision by the Clinical Research Manager:
· 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
· Submit Data and Safety Monitoring Reports
· 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 file all monitoring visit correspondence
· Ensure appropriate documentation of delegation and training for all study staff members
· Maintain screening and enrollment logs
Skills/Abilities/Competencies Required
· Careful attention to detail
· Good organizational skills
· Ability to follow directions
· Good communication skills
· Computer literacy
· Working knowledge of clinical research protocols

Job Summary:

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. Will be trained on the institutional and federal regulations governing clinical research.

Does this position require Patient Care?
No

Essential Functions
-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 and organize study-specific regulatory binders.

-Manage adverse events and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.

-Submit Data and Safety Monitoring Reports.

-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 file all monitoring visit correspondence.

Qualifications:

Education:

Bachelor's Degree Related Field of Study required:

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials:

Experience:

• Knowledge, Skills and Abilities
• Careful attention to detail.
• Good organizational skills.
• Ability to follow directions.
• Computer literacy.
• Working knowledge of clinical research protocols.

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

Scheduled Weekly Hours:

40

Employee Type

Regular

Work Shift

Day (United States of America)

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. 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:

0100 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 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.