University of Colorado Research Regulatory Specialist in Aurora, Colorado

**Applications are accepted electronically ONLY atwww.cu.edu/cu-careers.


University of Colorado Denver l Anschutz Medical Campus

School of Medicine, Department of Obstetrics and Gynecology

Research Regulatory Specialist (Research Services Intermediate Professional)

Position #752404 – Requisition 14595


The Department of Obstetrics and Gynecology has an opening for a full-time, University Staff (unclassified) Research Regulatory Specialist (Research Services Intermediate Professional) position.

The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002. Read CU Anschutz Quick Facts here.

_Nature of Work:_

The Department of Obstetrics and Gynecology is seeking applications for a Research Regulatory Specialist. This full-time, University Staff position is responsible for providing operational support to the Department Faculty which includes planning, organizing and managing all activities related to human subjects research and Institutional Review Board (IRB) submissions. This position will be responsible in part for ensuring departmental compliance with diverse federal, state and university regulations, policies, and procedures governing OB/GYN clinical research efforts. This position will be responsible for managing research projects and will have authority to make business decisions as they relate to the oversight of these functions.

_Examples of Work Performed:_

  • Support investigators in submitting complete and accurate clinical research applications to all required regulatory bodies in order to conduct clinical research at the University of Colorado, including:

o Institutional Review Boards (IRBs)

o Hospital Research Administration Offices (UCH, CHCO, Denver Health)

o University of Colorado Scientific Advisory & Review Committee (SARC)

o Oncology Protocol Review and Monitoring System (PRMS)

o US Food and Drug Administration (FDA)

o Various industry sponsors or other institutional entities as required by the research projects

  • Develops clear and accurate subject informed consent documents and HIPAA authorization documents for investigators.

  • Maintains a comprehensive record keeping system of clinical research data and reports metrics of productivity on a monthly basis to Department research leadership.

  • Reviews and interprets relevant federal, state, local, and university rules, regulations, and guidelines and communicate these to OB/GYN investigators and research assistants.

  • Routes Data Use Agreements (DUAs) and Material Transfer Agreements (MTAs) for execution.

  • Maintains regulatory document e-files for each clinical research protocol.

  • Conducts quality assurance reviews of research participant and study files and advises on best practices relating to clinical research.

  • Develops and presents educational content to department research faculty, staff, and professional research assistants at quarterly research meetings, faculty meetings, and other meetings as necessary.

  • Develops original content for department research edition newsletter, including advising research personnel on changing regulations and policies/procedures.

  • Identifies and participates in training opportunities to enhance knowledge in all areas of responsibilities.

  • Serves as regulatory liaison between OB/GYN researchers and University committees involved in the review and approval of research projects.

  • Assists the research services manager with developing general research policies and procedures relating to clinical research, and is independently responsible for development.

PLEASENOTE:Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable

_Salary and Benefits:_

The hiring salary for this position is negotiable and commensurate with skills and experience. This position is not eligible for overtime.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Benefits:https://www.cu.edu/employee-services/benefits.

Total Compensation Calculator:https://www.cu.edu/employee-services/total-compensation

The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

_Minimum Qualifications_

  • A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution

  • Research experience which includes at least one (1) year of experience working in an academic research or related environment.

Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis, but not for the specific experience.

_Preferred Qualifications_

  • Three (3) or more years’ of experience working in a research environment.

  • Experience in the conduct or oversight of Human Subjects Research.

  • Certified Clinical Research Professional (CCRP).

_Competencies/Knowledge, Skills and Abilities_

  • Excellent knowledge regarding Human Subject Research regulations and principles of ethical conduct.

  • Ability to work in a fast-paced environment requiring administration of 100 active research projects.

  • Outstanding customer service, time management, problem solving, and interpersonal skills.

  • Effective communication/presentation skills and a proven track record of forming collaborative and effective working relationships with physicians and administrative leaders.

  • Knowledge, experience, and ability to manage complex information and computer systems.

  • Demonstrated ability to self-manage priorities and be proactive in resolving issues.

  • Demonstrated commitment and leadership ability to advance diversity and inclusion

_Diversity and Equity:_

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Office of Equity by email at equity_ada@ucdenver.edu or by phone at (303) 315-2567.

The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Job: *Research Services

Organization: *H0001 -- Anschutz Medical Campus

Title: Research Regulatory Specialist

Location: Aurora

Requisition ID: 14595