IRB & Research Compliance Manager
- Spartanburg, SC
- Spartanburg Medical Center
- Institutional Review
- Job Grade E13
- Req #: 38956
The Manager, Research Compliance provides a high-level of administrative services and leadership for the day-to-day operations of the Office of Research Compliance (ORC). The ORC seeks to ensure the safe, ethical and responsible conduct of research at Spartanburg Regional Healthcare System(SRHS). The Manager plays a key role in assuring compliance with federal regulations related to the protection of human subjects in research, development and implementation of appropriate research auditing and monitoring programs, management and reporting of research misconduct, review of research conflicts of interest consistent with SRHS policy, conduct of research training programs.
The Manager participates in the development and support of research compliance solutions to improve compliance, business efficiency and productivity for research and all of its internal and external functions including the Institutional Review Board (IRB). The Manager monitors compliance with federal regulations governing clinical trials and research through practice, professional societies and other documented resources as appropriate. Monitors changes in the research compliance and clinical research compliance environment including OIG, CMS, OHRP, AAHRPP and other
federal or national guidance or publications. Communicates regulatory changes to internal and external clinical trials and research functions including necessary updates and change recommendations. Interacts with the VP, Corporate Integrity, Corporate Integrity compliance staff, clinical and non-clinical researchers and local IRBs on a regular basis. Provides administrative activities supporting clinical trials and research compliance. This includes project planning, audit design, record keeping, policy development, research compliance education, end user research compliance feedback and corrective actions. Actively participates in all workgroups to assure SRHS compliance with federal regulations governing Institutional Review Boards, Clinical Research, Clinical Trials and Spartanburg Regional Healthcare System standards and policies. Responsible for the oversight and management of the IRB Program, the IRB Coordinator, and the IRB’s purpose of protecting the welfare of human research participants while facilitating important research. The Manager is responsible for the administrative duties of facilitating the review and approval process, of providing relevant regulatory, policy, and ethical principal guidance and instruction essential to this process, and of maintaining SRHS clinical research and IRB policies and procedures as part of the institution’s HRPP.
- Bachelors level or higher in healthcare or related field.
- 3 + years’ experience in Clinical Research, Research Compliance, Institutional Review Board and/or AAHRPP accreditation guidelines
- Extensive database and computer usage knowledge
- 3 + years research compliance regulatory guidance experience.
- Certified Clinical Research Professional (CCRP)
- Certified Healthcare Research Compliance (CHRC)
- Certified IRB Professional (CIP)
- Certified IRB Manager (CIM)
- Other Research Compliance Certification or eligibility considered
Core Job Responsibilities
- Represents the clinical and research compliance needs of SRHS in the development and integration of research compliance activities.
- Coordinates the research compliance program to assure that SRHS needs are addressed.
- Coordinates ongoing associate and leadership education regarding research compliance guidance, audit activities, audit outcomes and other research compliance activities as appropriate.
- Provides oversight activities of research compliance internal and external audit deficiencies and corrective actions.
- Provides daily administrative support relative to research compliance across SRHS, including interactions with clinical trials research, clinical trials management, cancer research, oncology drug/Pharma research, device research, educational and outreach research activities, nursing research, investigator initiated research, any SRHS participation in outside research efforts, IRB research compliance needs and other research compliance needs as identified and appropriate.
- Addresses all ongoing research compliance needs identified through direct contact, systems reports, external reports, audits and federal regulations.
- Serves as a resource to the Institutional Official, the Office of General Counsel and the VP, Corporate Integrity concerning the conduct of responsible and compliant conduct of research, interpretation of research requirements, and submission of any necessary and appropriate communications between SRHS and Federal and State entities to report any mandated reportable events.
- Provides interpretation of human research regulations to promote institutional compliance.
- Offers guidance and support of IRB members, investigators, research coordinators, staff and others involved in the conduct of human research.
- Develops policies and procedures to ensure compliance with governmental regulations and institutional policy.
- Prepares annual research audit plan initiatives for review and incorporation in Corporate Integrity Annual Audit Plan & Key Initiatives.
- Conducts audits of active studies as needed.
- Maintains and monitors human research ethic training program for IRB members, investigators, and others involved in clinical research projects.
- Communicates with the Research Division, investigators, other SRHS entities as needed to promote efficient and effective processes for IRB submission and follow-up.
- Demonstrates ability to work collaboratively to successfully develop, implement and monitor programs and processes.
- Participates in multidisciplinary task forces, committees and projects, demonstrating team building skills and ability to work with different internal customers.
- Acts as Clinical Systems Analyst as needed in eIRB maintenance
- Creates and manages annual department budget.
- Participates in conferences, workshops, and other professional development activities to maintain certifications and/or remain professionally current with advances in area of expertise.
- Directly supervises ORC associates to include assigning and directing work, appraising work performance, managing associate corrective actions (as directed by SRHS Human Resources Department), addressing department complaints and resolving department problems.
Additional InformationSpartanburg Regional is an integrated healthcare system that provides care from birth to hospice. As a a partner with the community for 90 years, we have earned a reputation for technological excellence. With more than 5,600 employees, Spartanburg Regional prides itself in being one of the most recognized healthcare facilities in Upstate South Carolina. A long list of accolades and accomplishments keep our employees proud. We believe the pride and quality in our organization is the result of a focused effort of our staff and resources.