Boston Medical Center
Conflict of Interest & Research Compliance Manager
Boston Medical Center, Boston, Massachusetts, us, 02298
Conflict of Interest & Research Compliance Manager
POSITION SUMMARY:
Reporting directly to Boston Medical Center (BMC) Research Compliance Officer and with close working relationships with BMC Health System's (BMCHS) Research Operations and Boston University Office of Human Research Affairs (OHRA), the Conflict of Interest & Research Compliance Manager serves as an expert in all matters related to Conflict of Interest (COI), providing training and guidance to COI Committee members, BMC faculty, staff and researchers. The Conflict of Interest & Research Compliance Manager assists with the oversight and monitoring of the research compliance plan (including COI) that supports the BMC compliance program. The Conflict of Interest & Research Compliance Manager is responsible for the day-to-day coordination of the conflict of interest process for Boston Medical Center and the WellSense Health Plan and for the day-to-day management of conflict of interest and research-related audits, investigations, education, and policies. The Conflict of Interest (COI) & Research Compliance Manager will provide subject matter expertise on COI and other research compliance issues and will assist oversight committees, boards, and offices responsible for specific elements of COI & research compliance with ensuring compliance with research-related regulatory requirements.
ESSENTIAL DUTIES/RESPONSIBILITIES:
Assists the Research Compliance Officer in overseeing the Conflict of Interest and Research Compliance Program, maintaining extensive and current knowledge of health care and research compliance regulatory requirements including conflicts of interest and other areas of research.
Manages the individual and institutional conflict of interest and commitment programs for BMCHS trustees, employees, investigators and medical staff subject to BMC & WellSense Health Plan policies.
Manages the annual and ongoing conflict of interest reporting processes, including data collection for the IRS Form 990, and follows up with disclosers, as needed.
Completes initial review, analysis and summary of data and documentation for conflict of interest disclosures for determination of research, clinical, administrative or board of trustee conflicts.
Manages and coordinates the activities of both the BMCHS Conflict of Interest Committee and the Boston University/Boston Medical Center Faculty Committee on Research Conflicts, including preparing meeting agendas, cases and materials, as well recommending, implementing, and monitoring conflict of interest management plans.
Ensures appropriate federal reporting of conflicts of interests, tracks compliance with management plans, oversees BMC’s review of and response to information compiled by CMS under the Physician Payments Sunshine Act.
Manages the online conflict of interest reporting system and coordinates with IT, Research Operations and others regarding system updates and reporting, and regularly tracks the conflict of interest online system, including review and disposition of open issues.
Interprets laws, guidance and regulatory changes governing research and determines applicability to BMCHS.
Responds to inquiries and activities relating to conflict of interest and other research compliance topics.
Assists with internal and external audits, inquiries, and investigations related to conflicts of interest and other research-related compliance issues including human research protections, animal welfare, environmental health & safety, export controls, clinical research billing, and research misconduct.
Implements policies and procedures that govern the conflict of interest & research compliance program and ensure the program is structured to prevent, detect, and equitably resolve research compliance issues.
Develops and recommends research work plans, audits and projects, and reports conclusions and recommendations to ensure an effective and objective approach for evaluating and improving conflict of interest & research compliance program.
Collaborates on investigations of matters of suspected non-compliance with appropriate business units to determine the appropriate plan of action/discipline for personnel engaging in noncompliant conduct.
Administers communication and training programs to the BMC community on research compliance-related matters, including without limitation, conflict of interest issues and applicable federal and state laws. Creates and delivers education related to conflict of interest & research compliance using online and in-person training, job aids, tip sheets, newsletters, and articles in prominent internal publications.
Leads by example and sets the tone of a culture of compliance for the BMC community.
Performs other related duties as assigned or directed to meet the goals and objectives of the department and BMCHS.
JOB REQUIREMENTS
EDUCATION:
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) or Certified Clinical Research Professional (CCRP) preferred
EXPERIENCE:
Minimum 5-7 years of experience in research and related regulatory matters. Experience with federal regulations and guidelines pertaining to clinical and basic research is required. Previous conflict of interest management experience preferred. Research Compliance experience in a health system or academic medical center preferred.
KNOWLEDGE AND SKILLS:
Familiarity with Public Health Service regulations and experience in management of conflict of interest programs or other research compliance processes.
Knowledge of and experience interpreting and applying 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, including Excel.
Equal Opportunity Employer/Disabled/Veterans
#J-18808-Ljbffr
POSITION SUMMARY:
Reporting directly to Boston Medical Center (BMC) Research Compliance Officer and with close working relationships with BMC Health System's (BMCHS) Research Operations and Boston University Office of Human Research Affairs (OHRA), the Conflict of Interest & Research Compliance Manager serves as an expert in all matters related to Conflict of Interest (COI), providing training and guidance to COI Committee members, BMC faculty, staff and researchers. The Conflict of Interest & Research Compliance Manager assists with the oversight and monitoring of the research compliance plan (including COI) that supports the BMC compliance program. The Conflict of Interest & Research Compliance Manager is responsible for the day-to-day coordination of the conflict of interest process for Boston Medical Center and the WellSense Health Plan and for the day-to-day management of conflict of interest and research-related audits, investigations, education, and policies. The Conflict of Interest (COI) & Research Compliance Manager will provide subject matter expertise on COI and other research compliance issues and will assist oversight committees, boards, and offices responsible for specific elements of COI & research compliance with ensuring compliance with research-related regulatory requirements.
ESSENTIAL DUTIES/RESPONSIBILITIES:
Assists the Research Compliance Officer in overseeing the Conflict of Interest and Research Compliance Program, maintaining extensive and current knowledge of health care and research compliance regulatory requirements including conflicts of interest and other areas of research.
Manages the individual and institutional conflict of interest and commitment programs for BMCHS trustees, employees, investigators and medical staff subject to BMC & WellSense Health Plan policies.
Manages the annual and ongoing conflict of interest reporting processes, including data collection for the IRS Form 990, and follows up with disclosers, as needed.
Completes initial review, analysis and summary of data and documentation for conflict of interest disclosures for determination of research, clinical, administrative or board of trustee conflicts.
Manages and coordinates the activities of both the BMCHS Conflict of Interest Committee and the Boston University/Boston Medical Center Faculty Committee on Research Conflicts, including preparing meeting agendas, cases and materials, as well recommending, implementing, and monitoring conflict of interest management plans.
Ensures appropriate federal reporting of conflicts of interests, tracks compliance with management plans, oversees BMC’s review of and response to information compiled by CMS under the Physician Payments Sunshine Act.
Manages the online conflict of interest reporting system and coordinates with IT, Research Operations and others regarding system updates and reporting, and regularly tracks the conflict of interest online system, including review and disposition of open issues.
Interprets laws, guidance and regulatory changes governing research and determines applicability to BMCHS.
Responds to inquiries and activities relating to conflict of interest and other research compliance topics.
Assists with internal and external audits, inquiries, and investigations related to conflicts of interest and other research-related compliance issues including human research protections, animal welfare, environmental health & safety, export controls, clinical research billing, and research misconduct.
Implements policies and procedures that govern the conflict of interest & research compliance program and ensure the program is structured to prevent, detect, and equitably resolve research compliance issues.
Develops and recommends research work plans, audits and projects, and reports conclusions and recommendations to ensure an effective and objective approach for evaluating and improving conflict of interest & research compliance program.
Collaborates on investigations of matters of suspected non-compliance with appropriate business units to determine the appropriate plan of action/discipline for personnel engaging in noncompliant conduct.
Administers communication and training programs to the BMC community on research compliance-related matters, including without limitation, conflict of interest issues and applicable federal and state laws. Creates and delivers education related to conflict of interest & research compliance using online and in-person training, job aids, tip sheets, newsletters, and articles in prominent internal publications.
Leads by example and sets the tone of a culture of compliance for the BMC community.
Performs other related duties as assigned or directed to meet the goals and objectives of the department and BMCHS.
JOB REQUIREMENTS
EDUCATION:
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) or Certified Clinical Research Professional (CCRP) preferred
EXPERIENCE:
Minimum 5-7 years of experience in research and related regulatory matters. Experience with federal regulations and guidelines pertaining to clinical and basic research is required. Previous conflict of interest management experience preferred. Research Compliance experience in a health system or academic medical center preferred.
KNOWLEDGE AND SKILLS:
Familiarity with Public Health Service regulations and experience in management of conflict of interest programs or other research compliance processes.
Knowledge of and experience interpreting and applying 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, including Excel.
Equal Opportunity Employer/Disabled/Veterans
#J-18808-Ljbffr