Regulatory Affairs Project Manager
University of Colorado Denver l Anschutz Medical Campus University of Colorado Cancer Center Regulatory Affairs Project Manager Position # 00611437 - Requisition 08709 * Applications are accepted electronically ONLY at www.cu.edu/cu-careers * The University of Colorado Cancer Center, located at the Anschutz Medical Campus, is Colorado's only National Cancer Institute-designated comprehensive cancer center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center's clinical partner for adult care, University of Colorado Hospital is ranked in the top 25 by U.S. News and World Report for cancer care and Children's Hospital Colorado is ranked 9th by the same organization. The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network®, an alliance of the nation's leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America's top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center is a consortium of approximately 400 researchers and physicians at three state universities and three clinical institutions, all working toward one goal: Translating science into life. Job Summary: As a senior member of the Clinical Protocol Data Management (CPDM) team, the Regulatory Affairs Project Manager works with investigators and CPDM team members in the development and implementation of investigator-initiated clinical trials as well as other select Cancer Center trials including the ORIEN project. This position is accountable for providing regulatory oversight for all clinical research projects within his/her assigned unit and assures compliance with FDA Regulations, and ICH/GCP Guidelines. This position is responsible for completing submissions to the FDA for IND applications as required for investigator-initiated trials. The incumbent is responsible for overseeing and supervising CPDM regulatory staff and ensuring completion of regulatory start up and maintenance tasks. This position communicates appropriately and effectively with study investigators, other team members and regulatory bodies such as FDA, COMIRB, UCH RSS; has outstanding customer service skills and participates in ongoing efforts to improve regulatory practices, procedures, and workflows. Salary and Benefits: The hiring salary for this position is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services. 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:
- Bachelor's Degree in any field
- Clinical Research Certification (CCRC, CCRA, RAC, etc.)
- The position requires extensive, diverse and progressively responsible experience at the management level, including direct responsibility for clinical research, regulatory affairs, and personnel management.
- Substitution: Clinical research regulatory experience may substitute for the degree only on a year for year basis. For example, 4 years of clinical research regulatory experience may substitute for the bachelor's degree, but NOT for the Clinical Research Certification.
- Oncology experience
- 3 years of clinical research regulatory experience
- Project management experience
- Experience with/understanding of contract language
- Experience with regulatory submissions to federal agencies (e.g., FDA)
- Experience with University of Colorado Denver regulatory policies and procedures
- Experience with filing Investigational New Drug Applications (INDs) and requesting IND exemption determinations.
- Ability to communicate effectively, both in writing and orally.
- Ability to quickly learn, interpret and master complex protocol information
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
- Possesses advanced knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials
- Demonstrated commitment and leadership ability to advance diversity and inclusion.
- Knowledge of medical terminology and computers.
- Ability to work with minimal supervision
- Outstanding customer service skills.