Research Integrity Program Manager

5 days ago

Somerville, MA, United States Mass General Brigham (Enterprise Services) Full time

Responsible for executing research misconduct activities such as sequestration, processing evidence, documentation of research misconduct activities, maintaining the chain of custody, transfer of evidence, attending panel meetings, and creating reports in collaboration with or on behalf of the Chief Research Compliance Officer for all research hospitals in the MGB system. Responsible for maintaining a regulatory accurate and current research misconduct policy and SOPs. Responsible for maintaining accurate information posted on the Research Integrity web page. Will serve as project manager to any research integrity initiatives as well as the Research Integrity Work group. Responsible for managing any other Research Integrity issues that arise involving Research Compliance, such as authorship disputes. This role involves collaboration with other departments within the network as well as Harvard Medical School (HMS).
Essential Functions:
-Maintain Research Misconduct policy and standard operating procedures in accordance with federal, state, and local regulations.
-Conducts assessments to identify potential risks and areas for improvement for efficiencies and leading practice in executing research misconduct regulatory requirements to include sequestration, processing evidence, documentation of research misconduct activities, maintaining chain of custody, and transfer of evidence.
-Coordinates training programs for staff on research integrity-related topics, ensuring understanding and adherence to regulations.
-Maintains up-to-date knowledge of research integrity topics and industry-leading practices related to regulatory implementation of research misconduct activities.
-Prepares and presents research misconduct reports to the Chief Research Compliance Officer. Attend panel meetings.
-Fosters a culture of compliance through effective communication and engagement with staff at all levels.
-Maintains case file directory in One drive for regulatory retention requirements and documentation of case activity. Maintains Research Integrity mailbox, saving all research misconduct related documentation in case files.
-Process sequestered evidence to maintain institutional regulatory obligations and transfer to HMS maintaining chain of custody.

Education

  • Bachelor's Degree Healthcare Administration, Law or related field of study required

  • Equivalent experience may be accepted in lieu of degree


Experience

  • 5-7 years of experience in healthcare compliance or a related field required

  • 2-3 years of experience working in a research misconduct/research integrity/research compliance field

  • 2-3 years of experience leading programs and/or projects required


Knowledge, Skills and Abilities

  • Proficient knowledge of healthcare laws, regulations, and accreditation standards.

  • Excellent leadership and interpersonal skills to engage and influence stakeholders at all levels.

  • Proficient analytical and problem-solving abilities to assess compliance risks and develop effective strategies.

  • Effective communication skills, both written and verbal, for reporting and training purposes.

  • Demonstrated ability to manage multiple projects and prioritize tasks in a fast-paced environment.

  • Detail-oriented with a proficient focus on accuracy and compliance in documentation and reporting.



Mass General Brigham Incorporated is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.

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