Senior Research Compliance Manager
Organizational Unit Overview
The newly configured Office of Research, led by the Chief Research Officer, partners and collaborates with different programs, assets, and resources across ECU campuses and facilities along with the UNC designated centers and institutes.
The Office of Research provides oversight of ECUs research enterprise, including grant administration and ethical practices; ensures compliance with the federal, state, and University rules and regulations; and includes the following units and committees or boards: Pre-Award Services, Post-Award Services, Research Administration Analytics, Research Development, Research Integrity and Compliance, Institutional Animal Care and Use Committee, and the University and Medical Center Institutional Review Board.
Job Duties
The Senior Research Compliance Manager assists with implementation and maintenance of a comprehensive Conflicts of Interest (COI), Conflicts of Commitment (COC), Export Controls (EC), and Research Security Program that includes training, policy and procedure development, monitoring, reporting, and enforcement. This position proactively collaborates with institutional leaders regarding compliance risks, controls, and new developments in research-related compliance laws and regulations. This position serves as a liaison with the Human Research Protection Office, the Office of Licensing and Commercialization, Risk Management, Financial Services, Office of Research Administration, Procurement, and ECU Health, a primary site for clinical trials, education, and research, to ensure compliance.
The Senior Research Compliance Manager makes independent decisions regarding the management of the institutions objectivity in research programs, ensuring employees complete research related project specific disclosures; performs reviews of research-related activities and relationships; develops management plans; performs annual management plan review; convenes the COI Committee to review and ensure continued compliance with approved management plans, and performs routine monitoring of fully executed management plans. This position assists faculty, staff, students and committees in interpreting federal regulations and institutional policies and is responsible for working with faculty to address, manage, and/or resolve research related conflicts of interest and incidences of noncompliance. The Senior Research Compliance Manager serves as the primary liaison with the Office of Research Administration for project specific COI disclosures and training in accordance with federal regulatory requirements.
The Senior Research Compliance Manager works with institutional leaders, faculty, staff, and students regarding compliance risks, foreign influence, and new developments in research-related compliance laws and regulations, such as the National Security Presidential Memorandum-33 (NSPM-33), which mandates the establishment of a research security program for institutions receiving Federal Research and Development support in excess of 50 million dollars per year.
The Senior Research Compliance Manager supports the Director by assisting with the management of the export controls compliance program, and provides training and advice to the administration, faculty, staff, and students regarding export and import matters. The export compliance program addresses all applicable export control laws, regulations, and requirements, including, but not limited to, Export Administration Regulations (EAR), Department of State International Traffic in Arms Regulations (ITAR), and the Department of Treasury Office of Foreign Assets Control (OFAC) Regulations.
The Senior Research Compliance Manager assists other staff in ORIC in discharging their responsibilities and provides appropriate training and guidance. This position supervises the Conflicts of Interest and Export Control Analyst and Export Controls Specialist positions, acts as a backup for these positions, and assumes responsibilities and oversight for the Director of Research Integrity and Compliance, when necessary.
This position routinely leverages and provides input about how the department uses various software applications and tools. These include, but are not limited to, COI Risk Manager, eTRACS, Descartes Visual Compliance, MS Word, MS Excel, MS Outlook, MS PowerPoint, Adobe Pro, and the U.S. Customs and Boarder Protections Automated Commercial Environment (ACE).
The Senior Research Compliance Manager works closely with Internal Audit and Management Advisory Services, and the Office of University Counsel in the development of policies and interpretation of statutes, policies, regulations, and guidance, and coordinates with Information Technology and Computing Services in the development and implementation of monitoring reports.
Performs other duties as assigned.
Contingent upon availability of funds.
Minimum Education/Experience
Post-baccalaureate education in a relevant scientific, health care, law, or administration/management discipline.
Knowledge of federal regulatory requirements regarding objectivity in research and export control laws.
2 years of progressive experience in administration of research compliance programs.
Excellent communication and interpersonal skills.
Preferred Experience, Skills, Training/Education
Experience in the following:
- Overseeing conflict of interest reporting and management at a major research institution or within a health care environment.
- Experience and training in Export Controls.
- Supporting, monitoring, or administering clinical trials, clinical practice, or clinical research.
Find Your Best Opportunity
Tell them AcademicJobs.com sent you!
