Position: Research Compliance Officer
Department: Compliance Office
Reporting to Boston Medical Center Health System's Vice President, Chief Compliance Officer, with close working relationship with BMC Health System's Office of General Counsel, Research Operations, Boston University Office of Human Research Affairs (OHRA), the Research Compliance Officer will be responsible for the development, oversight and monitoring of the research compliance plan that supports the BMC Compliance program. The Research Compliance Officer will serve as in-house expert on research compliance issues and will assist each oversight committee, board, and office responsible for specific elements of research compliance with ensuring compliance with research-related regulatory requirements.
ESSENTIAL RESPONSIBILITIES / DUTIES:
- Oversees the Research Compliance Program interpreting and applying regulatory laws and guidance governing research, including financial and non-financial regulations.
- Coordinates and administratively leads the biweekly Research Compliance Committee meeting
- Serves on both BMC- and Boston University-wide research committees including ad-hoc committees
- Coordinates activities with other BMC departments, including the Office of General Counsel, Research Operations, Information Security, Privacy, Conflict of Interest, as well as other stakeholders at Boston University including Office of Human Research Affairs (OHRA), Compliance (including, but not limited to, Conflict of Interest, Animal Care, Biosafety)
- Serves as BMC's subject matter expert for regulations and guidelines governing research, including, but not limited to, the Uniform Guidance, National Institutes of Health Grants Policy Statement, and regulations governing research conflicts of interest, human research protections, animal subjects protections, environmental health & safety, export controls, clinical research billing, and research misconduct.
- Demonstrates an understanding of current events that influence research guidelines and regulatory processes for both non-financial (e.g., human subjects protection, conflict of interest) as well as financial compliance
- Keeps current on new federal regulations, rules, revisions and other industry standards that govern research
- Attends and participates in local, state and national conferences related to Research Compliance and communicates knowledge gained at conferences and seminars
- Maintains membership in appropriate professional organizations and attends professional organization meetings
- Oversees internal investigations into research-related compliance issues and coordinates external investigations.
- Collaborates with key leadership, employees, physicians both at BMC and Boston University to identify, research, investigate and resolve research-related compliance issues
- Oversees and documents external research regulatory investigations and audits and assists as requested
- Partners with business units to ensure corrective action resulting from investigations is taken, including disciplinary action as applicable
- Tracks and trends research compliance-related allegations, investigations, and outcomes
- Provides communication and training to the BMC community on research compliance-related matters.
- Develops, coordinates, and participates in an educational training program that ensures compliance with pertinent policies and federal and state standards and augments training and communication for high risk areas, including, but not limited to, research misconduct, conflict of interest, foreign influence, etc.
- Creates and delivers education related to research compliance using online and in-person training, guideline documents, newsletters and other educational tools
- Oversees response to and communicates new regulatory changes to affected departments/individuals by assembling work groups and developing/providing education and training
- Implements policies and procedures that govern the research compliance program and ensure the program is structured to prevent, detect, and equitably resolve research compliance issues.
- Develops, implements and oversees institutional research-related compliance policies, procedures, guidelines and programs that enable the conduct of research while ensuring compliance with regulatory requirements
- In collaboration with the Compliance Office, conducts a risk assessment to proactively identify areas of research-related risk at BMC
- Develops and manages an annual research compliance work plan based off the risk assessment to reduce organizational risk, including data tracking, analysis and reporting to identify research compliance issue patterns
- Works with business units to define roles and responsibilities for research compliance-related activities, including activities of the research compliance program and operational responsibilities of business units
- Reviews annual reports from specific offices/departments responsible for elements of research compliance
- Participates in projects related to processes or systems that further promote an effective research compliance program
- Collaborates with BMC Health System Conflict of Interest Senior Manager on matters involving BMC investigators to ensure compliance with institutional Conflict of Interest and Conflict of Commitment Policies and recommend if proposed activity should proceed, as well as any action, including management plans required
- Leads by example and sets the tone of a culture of compliance for the BMC community
Bachelor's Degree required
Master's Degree in related field preferred (e.g., public administration, health administration, law, science)
CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED :
Research Compliance certification (CHRC) recommended
Minimum 8-10 years of experience in a research compliance environment, with experience in planning and implementing large-scale projects affecting multiple departments/functions. Previous research compliance officer experience preferred. Experience in a health system or academic medical center preferred
Minimum 4 years progressive supervisory experience, leading, supervising, or managing a team.
KNOWLEDGE AND SKILLS:
- Knowledge of and experience interpreting and applying federal laws, regulations and guidelines governing research, including research billing compliance
- Knowledge of federal laws, regulations and guidelines governing research
- Ability to present findings and discuss issues with providers confidently and effectively
- Ability to handle sensitive communications with leadership, legal counsel and regulatory agencies
- Strong attention to detail and highly organized
- Strong interpersonal, analytical and presentation skills
- Strong written and oral communication skills
- Strong team player with ability to work well independently and as a group
- Ability to work under pressure, multi-task and meet deadlines
- Technical capacity to utilize multiple information systems and Microsoft applications
Req id: 17145 Apply