Job Description

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Senior Research Compliance Specialist is responsible for contributing to the overall success of the research compliance program at Massachusetts General Hospital (MGH) as demonstrated by assisting with the development, oversight, and monitoring of research compliance functions through interpretation of MGH and Partners policy and local, state, and federal laws and regulations. The Senior Research Compliance Specialist should have a strong background in multiple research areas including, but not limited to, bench and laboratory research, animal research, human subjects research, international research activities, responsible conduct of research (RCR), research misconduct, research privacy, grants management, and controlled substances. The Senior Research Compliance Specialist will work under the direction of the Director of Research Compliance and in collaboration with compliance officials across Partners to ensure research compliance and consistency across all Partners entitities.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The Senior Research Compliance Specialist will have the following responsibilities:

• Assist with the development of an annual work plan based on risk assessment. Assist with development of metrics to measure program effectiveness.
• Conduct internal investigations and operational audits to assess risk of research related issues, identify potential research compliance vulnerabilities, and make recommendations to improve internal controls.
• Educate the research community on research related topics to achieve compliance utilizing communication styles such as PowerPoint presentations, articles, website development, in-person training sessions, handouts, and infographics.
• Stay abreast of requirements and changes in the regulatory environment and assist with interpretation and distribution of emerging MGH and Partners policies as well as local, state, and federal laws and regulations as it relates to research compliance.
• Evaluate issues of non-compliance to include investigation, oversight, follow up, and resolution.
• Assist in the development and revision of written research policies, procedures, and guidelines.
• Assist in maintaining the research compliance webpage with relevant and up-to-date information in collaboration with the web development staff.
• Utilize tact and diplomacy to communicate, build rapport and foster strategic alliances within the research community.
• Represent Research Compliance at committee meetings.
• Contribute to MGH and the Office of Compliance initiatives to promote a positive work environment.
• Perform other related duties and responsibility as required.

Qualifications

QUALIFICATIONS

• Baccalaureate Degree required.
• Graduate degree in a healthcare field or law is preferred; related healthcare or legal experience considered in substitution
• 3 years experience in project management in a complex organization is a plus.
• A minimum of 3-5 years in a research-related position, preferably in a research compliance role. Thorough familiarity with current applicable local, state, and federal laws and regulations related to research activities. 3-5 years experience in research administration preferred.
• CHRC certification preferred.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Proficient in using computer software applications such as Microsoft Excel, Word, PowerPoint, and Adobe.
• Demonstrated experience and knowledge of MGH\xe2\x80\x99s culture including strong interpersonal and communication skills (oral and written), including public speaking to facilitate training sessions, lead discussion groups, present to management.
• Ability to understand complex organizations; demonstrated political savvy.
• Strong project management skills
• Ability to work independently, with all levels, and within a strong team environment.
• Ability to manage multiple responsibilities, often under time pressures.
• Ability to function independently and effectively.

WORKING CONDITIONS:

• Traditional office space located within a busy hospital
• Frequent employee and professional contacts
• Pace of work is sometimes hectic and always challenging

SUPERVISORY RESPONSIBILITY:

None.

FISCAL RESPONSIBILITY:

No direct responsibility for budget.

Mass General Brigham