Clinical Research Regulatory Coordinator II

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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 Regulatory Affairs Coordinator II (RAC II) is part of our Regulatory Support Request Team (RESORT). They will be responsible for the collection, completion and submission of regulatory documents to and the Institutional Review Board (IRB). The RAC II works independently to monitor, track and facilitate regulatory reports to and from all the IRB committees. The position of RAC is also responsible for disseminating all updates on the clinical trial review process to the sponsor and the research study team.

Job Summary

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The following duties will be performed independently:

* Monitoring RESORT inbox throughout the day

* Provide support to study teams via e-mail and zoom

* Facilitate initial new trial submission for SRC and IRB review

* Maintain a working knowledge of the IRB's current guidelines

* Prepare and submit protocol amendments

* Prepare and submit continuing reviews

SKILLS/ABILITIES/COMPETENCIES

REQUIRED:

Ability to work independently and as a team member

Careful attention to detail

Computer literacy

Analytical skills and ability to resolve problems

Excellent oral and written communication skills

Strong interpersonal skills

Strong organizational skills

Qualifications

Education

Bachelor's Degree required

Can this role accept experience in lieu of a degree? No

Licenses and Credentials

Experience

Regulatory Affairs Experience 2-3 years required

Open to other experience areas that would transfer

Knowledge,

Skills and Abilities

* 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)

Remote Type

Remote

Work Location

101 Merrimac Street

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

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:

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 .

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…