Research Compliance Specialist

Wentworth-Douglass Hospital Belmont , MA 02178

Posted 5 months ago

McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to superior quality, cost-effective mental health services in the Boston area, Massachusetts and beyond. Since 1811, McLean Hospital has been a world leader in the treatment of mental illness and chemical dependency, research into the cause of mental illness and the training of generations of mental health care providers. McLean's multidisciplinary programs treat a broad range of psychiatric illnesses across the full continuum of care.

Reporting to the Compliance Officer, the Research Compliance Specialist is responsible for assisting with the development, oversight and monitoring of the research compliance functions of McLean. This position is of a highly confidential and discretionary nature and includes providing advice and interpretation of policy and procedures related to research compliance activities at McLean including, but not limited to: animal care and use; protection of human subjects; export controls; billing rules for clinical trials; grants management issues; policy development and interpretation; privacy/HIPAA issues related to research and controlled substances.

Together with the Compliance Officer, the Research Compliance Specialist promotes research compliance best practices and solutions and contributes to the overall success of the Hospital compliance program.

  • Interprets and applies federal and state laws, regulations, institutional policies, and guidelines and assist in the development of research compliance policies and procedures in response to rapidly evolving state and federal laws and regulations.

  • Develops and delivers research compliance training and education curriculum for McLean personnel; creates training tools and materials (training aids, newsletters, brochures, handouts, etc.) on various research compliance related topics to achieve individual and group learning goals.

  • Evaluates instances of non-compliance with further investigation and in coordination with Compliance Officer, oversees follow up and resolutions including corrective action.

  • Provides direction, training, and consultation to investigators and research staff regarding current research compliance issues and ethical concerns.

  • Assists with review and oversight of conflict of interest disclosures related to research; in coordination with the Compliance Officer, advises on conflict of interest policies and procedures related to conflict evaluations, management and applicable regulations.

  • Maintains accurate and comprehensive records of research compliance activities and other reports as necessary to comply with appropriate regulations.

  • Performs other work-related duties as assigned.

All McLean team members are expected to consistently demonstrate our values of integrity, compassion, respect, diversity, teamwork, excellence and innovation in their work activities and interactions.

  • Bachelor's degree required.

  • 3 years of experience in health care, research compliance experience required.

  • Strong computer skills and experience with Microsoft Office (Access, Excel, Word) required.

  • Must have strong interpersonal and oral/written communication skills as well as the ability to work well with individuals at all levels within the institution.

  • Ability to address problems that are highly varied, complex and often non-recurring, requiring staff input, innovative, creative, and resolve issues.

  • Make decisions that are guided by precedents, policies and objectives. Regularly makes decisions and recommendations on issues affecting a department/lab or functional area.

  • Must be a self-starter with the ability to work both independently and as part of a team.

All employees must possess basic computer skills to use a variety of electronic or online systems for communication, clinical and administrative purposes.


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Research Compliance Specialist

Wentworth-Douglass Hospital