Research Compliance Manager

University of Northern Colorado•Greeley, CO

4d•Onsite

About The Position

The Research Compliance Manager is responsible for overseeing all aspects of research protections and regulatory compliance at UNC. This position ensures that research activities undertaken at UNC meet UNC, state, and federal regulations.

Requirements

Master's degree in an appropriate field, or a bachelor's degree with at least four years’ experience in research compliance.
Valid U.S. work authorization at the time of application.

Responsibilities

Serves as the IRB Administrator and as an Advisory Member on the Institutional Review Board.
Serves as the primary point of contact with the internal and external research community, utilizing expertise in regulatory matters and IRB policies.
Assists investigators in the preparation of IRB applications, contracts, and informed consent forms.
Manages review of protocol submissions via Streamlyne to ensure the category of review is appropriate, and that protocol materials follow institutional policies, procedures and federal regulations.
Maintains documentation of protocols and actions taken through the course of a research project so that record-keeping is in compliance with federal regulations and available for internal and federal regulatory audits.
Establishes and maintains protocol records and a database for human subjects research.
Creates statistical and administrative reports related to IRB activity and human subject research.
Prepares and presents information to IRB Chairs and board members.
Assists in overseeing IRB expenditures and in making budgetary recommendations so that institutional support to the IRB can be documented and presented to federal regulatory agencies in the case of an institutional compliance review.
Prepares and submits UNC’s Federal Wide Assurance to the Office of Human Research Protections that documents compliance with federal human subjects’ protections.
Manages the IRB Authorization Agreement process when other research sites are involved.
Serves as the Administrator of the Institutional Animal Care and Use Committee (IACUC) and as an Advisory Member on the IACUC.
Oversees all compliance related to research, training, testing, and teaching with live vertebrate animals by UNC personnel.
Assists investigators in the preparation of IACUC applications and appropriate research activities.
Maintains documentation of protocols and actions taken through the course of a research project so that record-keeping is in compliance with federal regulations and available for internal and federal regulatory audits.
Establishes and maintains protocol records and a database for vertebrate research.
Creates statistical and administrative reports related to IACUC activity and human subject research.
Prepares and presents information to the IACUC Chair and committee members.
Assists in overseeing IACUC expenditures and in making budgetary recommendations so that institutional support to the IACUC can be documented and presented to federal regulatory agencies in the case of an institutional compliance review.
Prepares and submits UNC’s assurance through Office of Laboratory Animal Welfare (OLAW) that documents compliance with Public Health Service (PHS) policy.
Oversees the UNC Animal Research Facility (ARF), including regularly inspecting ARF to ensure animals are receiving appropriate care.
Oversees training for ARF staff.
Manages the ARF budget.
Supervises the ARF Manager.
Manages UNC policies related to Financial Conflict of Interest (FCOI) based on federal guidelines.
Sends the annual FCOI survey to all staff conducting research via Streamlyne.
Reviews all FCOI responses to make a determination if conflict exists.
Works with the AVP of Research to mitigate any identified FCOI.
Ensures that all Principal Investigators (PI’s) receiving funding from the PHS have undergone the additional required training based on UNC policy.
Oversees compliance training activities for UNC faculty, staff, and students.
Serves as administrator for the CITI web-based training platform.
Ensures that UNC has appropriate CITI training modules to meet federal compliance requirements.
Confirms faculty, staff, and student completion of appropriate training.
Develops training as needed to support compliance needs.
Assist with other duties assigned by ORSP leadership.

Benefits

Health insurance
Dental insurance
Vision insurance
Life insurance
Long-term disability insurance
Selection of several defined contribution retirement plans
Sick leave
Other leave options may be available based on position
Tuition waiver benefits for full-time employees
Undergraduate dependent tuition grants of up to 50% for dependents and spouses of UNC Employees who are employed at 0.5 FTE or above (covers in-state tuition charges)