Research Compliance Program Director
Jobs in this career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post- and pre-award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.
Program Directors are responsible for the ongoing leadership and oversight of a program or function, including the development of strategies and processes which contribute to the University and/or campus mission and accountability for services provided. These positions may or may not supervise others.
Nature of Work:
This position, reporting to the Associate Director of the Office of Sponsored Programs and Research Integrity (OSPRI), is responsible for performing the day-to-day management of the Institutional Review Board for the Protection of Human Subjects (IRB) activities including IRB audit, monitoring compliance with the Responsible Conduct of Research (RCR) requirements, assisting in the development of standard operating procedures and document management processes for research compliance areas, developing and delivering training programs for research compliance areas, and performing other activities in support of research compliance and sponsored programs.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Develop processes, policies, and procedures to ensure the smooth work flow, timeliness, and compliance of IRB review of research protocols
- Collaborate with the Associate Director of OSPRI and others, as appropriate, to develop policies, procedures, and data management processes
Review IRB protocols, record of changes, unanticipated problem reports, and any other related documents for compliance with university and federal requirements and communicate required corrections/additions to the investigator(s) and/or chair/co-chair. Review IRB applications to generally determine level of review prior to assigning protocol for review or forwarding to the IRB committee
Implement and manage an electronic IRB software system and workflow process for faculty, students and IRB reviewers
Responsible for vendor relations and serving as the main point of contact for the IRB software vendor
Maintain professional communication with principal investigators, IRB chair/co-chair, IRB committee members, and others to ensure smooth progress of research studies involving human subjects review and approval, such as following up on renewal applications, submission of additional documents and/or revised documents, and timely preparation of approval documents
Audit meeting agendas and minutes to ensure complaint with federal regulations and SOPs
Develop, refine, and perform quality assurance processes to ensure compliance with appropriate regulations regarding IRB, RCR, export controls, and other research compliance areas, in consultation with the Associate Director of OSPRI and others, as appropriate
Responsible for internal research audit programs: design, develop, implement, evaluate, and modify internal research auditing program, policies, procedures, systems, and documentation. This position will develop audit programs and will recommend strategy
Organize and perform random, for-cause, and -requested audits for research compliance
Analyze data and prepare/present audit reports and summaries to appropriate stakeholders
Identify educational needs of researchers and design, develop, deliver, and evaluate targeted training programs and materials
Collaborate with the HIPAA privacy board and the Registrar's Office for FERPA as it relates to human subject's research
Actively participate in research compliance committees and other campus committees, as appropriate
Collaborate with the Associate Director of OSPRI and Executive Director of OSPRI on special projects as assigned
- Maintain confidentiality
- Maintain the highest ethical standards
- Ability to communicate and work with diverse individuals in a professional setting
- Communicate effectively in both verbal & written forms
- Excellent analytical and time management skills
- Ability to edit and write clear, precise, and grammatically correct documents
- Ability to work independently while exercising appropriate judgment in seeking assistance and guidance
- Work effectively under pressure
- Manage a heavy workload with multiple deadlines and competing priorities
- Create and manage documents, databases, and spreadsheets in Word, Access, and Excel
- Interpret complex material
- Translate regulatory requirements into operational policies, processes, and procedures
- Maintain a sense of humor
- Proficient in Word, Access, Excel
- Establish and maintain effective and collaborative working relationships
Communicate effectively with all members of the university community, including students
Experience developing and delivering training
Experience with electronic research administration
For the purposes of FLSA, this position has been determined to be exempt from (not eligible for) overtime under FLSA.
Salary Range: $57,000 - $63,000
The University of Colorado Colorado Springs offers a full benefits package. Information on university benefits programs, including eligibility, is located at http://www.cu.edu/employee-services.
The University of Colorado Colorado Springs is committed to providing a safe and productive learning, living and working community. To assist in achieving this goal, we conduct background investigations for all prospective applicants being considered for employment. Background investigations include a criminal history record check, and when appropriate, a financial and/or motor vehicle history check.
- Bachelors' degree and
- At least 4 years of experience in compliance activities
- Master's degree
- Knowledge of principles of ethical conduct of research with human subjects
- Knowledge of applicable federal regulations (OJRP, HHS, NSF, DOD, NIH and other government agencies) related to human subjects protections, responsible conduct of research, conflicts of interest, and other research compliance areas
- Experience developing and delivering training
Special Instructions to Applicants:• Applications submitted by September 24, 2018 will receive full consideration. • Applications submitted through email or surface mail will not be considered. Please apply at www.cu.edu/cu-careers. • Upon request, please be prepared to provide five professional references (at least two previous/current supervisors), including their email contact information. • Official transcripts will be required upon hire.
Successful Candidate must pass a background check to include license and educational verification, prior employment verification, sex offender registry check, criminal history, and credit history.
Application Materials Required:Cover Letter, Resume/CV, Unofficial transcript(s)
Application Materials Instructions:If you have technical difficulties with your application, please contact the CU Careers help desk at 303-860-4200 #5 or firstname.lastname@example.org. Job related inquiries should be directed to the posting contact.
Job Category: Research Services
Primary Location: Colorado Springs
Department: C0001 -- Colorado Springs Campus - 40020 - AA-Sponsored Research
Posting Date: Sep 10, 2018
Closing Date: Ongoing
Posting Contact Name: Deborah O'Connor
Posting Contact Email: email@example.com
Position Number: 00423392