Director of Research and Compliance

Employment Type:

Full time

Shift:

Day Shift

Description:

Director of Research and Compliance. Reporting to the SVP and Chief Clinical Officer - Trinity Health Michigan with accountability to System Integrity Officers for Organizational Integrity-related responsibilities, local ministry Institutional Officials/CMOs.

The scope of this position is regional & national and includes all Michigan, Georgia and Florida hospital locations, IHA and applicable medical groups owned by Trinity Health and Trinity Health Corporate.

The Research Compliance Director will be responsible for overseeing a comprehensive Research Compliance Program for Trinity Health Michigan, Georgia and Florida that addresses the regulatory requirements for the conduct of research, staff responsible for duties within Research Compliance, as well as directives from senior executives/institutional officials. This will include managing four Institutional Review Boards, that also act as the Privacy Board for adherence to Health Insurance Portability and Accountability Act (HIPAA) compliance. Provide a resource for training and educating IRB members, IRB staff and researchers to meet regulatory requirements. The director will be responsible for the implementation and oversight of review of on-going research (called program reviews) that provide in depth analyses and assessment of adherence to regulations and institutional policies in the conduct of research. Enhance programs to protect human research subjects, the integrity of the research enterprise, and partner with collaborators' regulatory affairs offices to improve efficiencies.

The director acts as the Research Conflict of Interest Officer, including oversight of the federal requirements and adherence to the corresponding Trinity Michigan Institutional policy Promoting Objectivity in Research-Financial Conflict of Interest (FCOI) Disclosure. Assures that disclosures are vetted and proper management plans are undertaken as requested by the FCOI committee. Reports conflict of interest disclosures and management plans to institutional officials and regulatory bodies as required by law.

Sets policy and procedure with regard to allegations of scientific misconduct and assures that proper committees are appointed to review allegations and for those that result into a formal investigation. Is responsible for assuring that misconduct in research is reported to the Institutional Official, the IRB, appropriate executive management and to regulatory authorities in a timely manner.

Sets policy and procedure and manages the audit program for adherence to the Centers for Medicare & Medicaid Services (CMS) regulations for billing of research. The director liaises with Trinity-Health (Regional Integrity Officers) to assure that policies and procedures are congruent with system expectations.

Under general supervision, directs the coordinating function for the Human Subject Protections program for Trinity-Health Michigan, Georgia and Florida. This position will:

• Provides critical management for research oversight through IRB committees charged with assuring, both in advance and by periodic review that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in approved research studies.

• Is integral in fulfilling the regulatory requirement of IRB functions and operations as required by law and is the institutional representative of the IRBs.

• Manages, implements and administers a broad spectrum of policies and procedures related to research compliance.

• Serves as a consultant to the IRB committees and investigators regarding current issues and ethical concerns related to research.

• Ensures that sensitive and confidential issues are concisely and clearly communicated, negotiated, resolved and properly documented as required by regulations, policies and procedures.

• Serves as the key contact for unanticipated problems occurring in research activities.

• Serves as key spokesperson to various committees and organizations.

• Develops, implements, evaluates and improves operational policies and procedures for the efficient and effective processing of research protocols.

• Directs and performs organizational training programs.

• Prepares inspectional and annual reports for submission to federal agencies such as the Office for Human Research Protection and other regulatory bodies. Performs additional related responsibilities as required.

• Serves as the host for FDA inspections and other regulatory bodies. Assures that periodic inspections are executed in conformance with the law and institutional policies.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Ensure research regulatory compliance in a manner that promotes Trinity mission and core values.

• Develop, initiate, maintain and revise research-related policies and procedures to prevent illegal, unethical or improper conduct. Provide oversight for the Institutional Review Boards (IRB). Make recommendations to the chairs of these committees regarding any compliance aspects of research involving human subjects.

• Ensure human research protection programs maintain appropriate federal assurances

• Provide oversight of the Financial Conflict of Interest (FCOI) disclosure and review process, and serve as chair of the Research Financial Conflict of Interest Committee.

• Manages and oversees the activities of the IRB Administrators, & Administrative Assistant and all research compliance team members.

• Serves on other committees as directed or requested (Research Committee, Biosafety) to provide input/recommendations regarding research compliance issues.

• Provide reports as directed or requested to keep executive management informed of the operation and progress of research compliance efforts.

• Oversees the conduct of internal monitoring and auditing of activities within scope of the conduct of research.

• Develop, coordinate, and participate in multifaceted educational and training programs that focus on the elements of the human subject research compliance program, and seek to ensure that all appropriate employees and management are knowledgeable of, and comply with, pertinent federal and state standards that govern human subject research activity.

• Consults with Regional Chief Clinical Officer, VP of Research Operations and Legal Council, Local hospital Institutional Offcials as needed to resolve human subject research compliance issues; respond to alleged violations of rules, regulations, policies, procedures.

• Responsible for research compliance as dictated by Federal regulations and institutional policies and procedures. Oversees the education and guidance to IRB members to assure that the board is equipped with current tools to protect the safety and welfare of human subjects in research. Knowledgeable of all types of clinical trials to assure that the applicable regulations are considered.

• Responsible for assisting the IRB Administrators and research compliance staff with evaluating clinical studies and associated study documents to assure patient rights and safety are appropriately addressed & upheld. Evaluates level of risk of human research protocols, consent forms, etc. and advises the IRB.

• Is responsible for organizing and leading inspectional activities with regulators such as the FDA.

• Reviews data obtained from the data safety monitoring, adverse events and auditing functions and will have the authority to recommend to the IRB to stop a protocol if, in his/her judgment, research participants have been, are, or will be placed at risk for serious harm.

• Independently composes and edits complicated and sensitive correspondence; reports and documents related to outcomes and findings of the human subject protection program. Prepares, analyzes and summarizes data from IRB activities to provide performance statistics for the Institutional Official IO and institutional executive management.

• Maintains good rapport and cooperative relationships. Approaches conflict in a constructive manner. Helps to identify problems, offer solutions, and participates in their resolution.

• Maintains the confidentiality of information acquired pertaining to patient, physicians, employees, and visitors to our Health System. Discusses patient and hospital information only among appropriate personnel in appropriately private places.

• Assumes responsibility for performance of job duties in the safest possible manner, to assure personal safety and that of coworkers, and to report all preventable hazards and unsafe practices immediately to management.

REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATION/LICENSURE

• M.B.A., M.S., or equivalent degree is required.

• Minimum of 5 years of compliance experience in an academic, research or other comparable environment, with specialized training/experience in the responsible conduct of research, regulatory affairs, and human subject protections.

• Knowledge of the drug development process and commercial clinical trial process is required.

REQUIRED SKILLS AND ABILITIES

• Thorough knowledge of research compliance and the regulatory requirements impacting a non-profit medical research facility.

• Strong interpersonal skills are critical to the role.

• The Research Compliance Director must be credible and effective in interacting with the Institute's leadership, compliance team, peer management leadership, investigators, clinical faculty, and outside regulatory officials.

• Excellent oral and written communication skills and an adaptable, cooperative and persuasive approach will be needed to succeed as part of this organization.

• Demonstrated ability to deal effectively and confidentially with difficult situations and with individuals at all organizational levels.

Total Rewards and Benefits

• Competitive compensation

• Benefits effective Day One! No waiting periods.

• Full benefits package including Medical, Dental, Vision, PTO, Life Insurance, Short and Long-term Disability

• Retirement savings plan with employer match and contributions

• Opportunity for growth and advancement throughout Trinity Health

Our Commitment to Diversity and Inclusion

Trinity Health is one of the largest not-for-profit, Catholic healthcare systems in the nation. Built on the foundation of our Mission and Core Values, we integrate diversity, equity, and inclusion in all that we do. Our colleagues have different lived experiences, customs, abilities, and talents. Together, we become our best selves. A diverse and inclusive workforce provides the most accessible and equitable care for those we serve. Trinity Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by law.

Our Commitment to Diversity and Inclusion

Trinity Health is a family of 115,000 colleagues and nearly 26,000 physicians and clinicians across 25 states. Because we serve diverse populations, our colleagues are trained to recognize the cultural beliefs, values, traditions, language preferences, and health practices of the communities that we serve and to apply that knowledge to produce positive health outcomes. We also recognize that each of us has a different way of thinking and perceiving our world and that these differences often lead to innovative solutions.

Our dedication to diversity includes a unified workforce (through training and education, recruitment, retention, and development), commitment and accountability, communication, community partnerships, and supplier diversity.

EOE including disability/veteran