Regulatory Compliance Specialist

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.

Job Summary

Summary: This position will guide investigators through the IRB review process and assist with the preparation and submission of protocol documents to the IRB and other regulatory committees ensuring regulatory compliance. Responsible for supporting the implementation and maintenance of the compliance program including conducting audits providing training monitoring compliance activities and assisting with investigations to promote a culture of ethical conduct and mitigate compliance risks within the organization.
Essential Functions:-Advising researchers and research teams on the requirements and standards for conducting approved research studies. Develop tools and resources to promote compliance and participate in education activities to support and guide researchers.
-Investigate review and report compliance concerns and reported events.
-Participate in compliance-related committees and subcommittees providing updates on compliance activities and contributing to discussions on compliance policy and similar matters.
-Administer the semiannual program review and facility inspection process ensuring all deficiencies are identified and corrected and prepare the report to the Institutional Official.
-Point of contact for all Federal State and local inspections and accreditation site visits as applicable.
-Conduct regular audits and risk assessments to identify potential compliance issues.
-Provide ongoing education on coding updates and changes in regulatory requirements.

Education
Bachelors Degree Related Field of Study required
Experience
Previous Compliance experience 2-3 years required

Knowledge Skills and Abilities
- Ability to work independently and with a team.
- Proficient written and verbal communication skills.
- Proficient organizational and attention to detail skills.
- Proficient understanding of federal regulations such as the Common Rule HIPAA and other relevant research compliance standards.
- Proficiency in using Microsoft Office and other relevant software applications.
- Knowledge of current and developing clinical research trends.

Onsite

185 Cambridge Street

40

Regular

Day (United States of America)

Pay Range

$63252.80 - $102596.00/Annual

Grade

7

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.

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 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