Regulatory Affairs Coordinator (Open Rank)

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Job description

University of Colorado | CU Anschutz Medical Campus
School of Medicine, The Cancer Center
Research Services Professional (Entry, Intermediate, or Senior - Open Rank)
Regulatory Affairs Coordinator (Level I, II, or III - Open Rank)
Position #706009 - Requisition #19874

* Applications are accepted electronically ONLY at *

*This position can be fully remote*

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

The Cancer Center has an opening for a full-time University Staff (unclassified) Regulatory Affairs Coordinator position.

The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.

The University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It 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 care sites are UCHealth, University of Colorado Hospital and Children's Hospital Colorado are ranked nationally by U.S. News and World Report.

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 includes six institutional partners made up of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.

The CU Cancer Center's vision is to "prevent and conquer cancer. Together." We do this through our mission statement of "uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education."

Nature of Work
As an important member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position works with Phase I-IV industry sponsored (Pharmaceutical), Cooperative Group (NCTN) and/ or Investigator initiated clinical trials in accordance with FDA Regulations, Good Clinical Practice (GCP) and applicable guidelines or policies. The successful candidate will be responsible for providing regulatory management and oversight for clinical trials. Specific duties may include writing accurate informed consent forms, submissions to applicable review committees (PRMS, IRB of record, UCHealth Research Administration), completion of Regulatory documents (Form 1572, Financial Disclosure forms), protocol amendment submissions and semi-annual or annual IRB continuing reviews.

This position is also responsible for knowledge of Unanticipated Problem reporting in order to guide clinical colleagues in their submission requirements. In order to succeed in this position, this detail-oriented individual must be able to demonstrate superior organizational skills in order to successfully track multiple tasks occurring in parallel. This incumbent must be self-motivated in order to complete tasks quickly and within set deadlines. This position is the 'hub' of communication between external (review committee coordinators, review committee members, study monitors) and internal (clinical study staff, investigators, clinical managers) contacts so superior communication skills (oral and written) are required.

Professional Field: Regulatory Affairs

Supervision Received: Regulatory Affairs Supervisor

Supervision Exercised: None

Examples of Work Performed for All Levels

• Serves as regulatory contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
• Writes clear and accurate consent/ HIPAA documents.
• Completes consents, applications and other required forms as per the applicable Institutional Review Board (IRB).
• Submits, tracks and processes protocol amendments for National Clinical Trials Network (NCTN) studies within the required 90 day period.
• Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Cancer Center. This may include, but is not limited to, the following:
  • Colorado Multiple Institutional Review Board (COMIRB)
  • Western Institutional Review Board (WIRB)
  • NCI Central Institutional Review Board (CIRB)
  • Protocol Review and Monitoring System (PRMS)
  • Hospital Research Support Services (UCH-RSS)
  • University of Colorado Hospital Clinical Trials Office (CTO)
• Completes and submits continuing reviews, amendments, and other protocol-specific documents.
• Completes and submits accurate federal forms, consents, HIPAA Authorizations, and obtains required approvals specific to the Denver VA medical Center.
• Navigates applicable NCTN websites. This may include Clinical Trials Support Unit (CTSU), Southwest Oncology Group (SWOG) and NRG Oncology (NSABP, RTOG, GOG).
• Updates OnCore with regulatory documents and dates.

Additional Duties for RAC II

• Assists in the completion of initial Institutional Biosafety (IBC) applications.
• Provides shadowing of daily tasks for new members of the Regulatory Affairs team.
• Serves as back up coverage during RAC absences.
• Assists in document collection and site regulatory communication for multi-center clinical trials.

Additional Duties for RAC III

• Potentially meets with representatives from Food and Drug Administration (FDA) for review of records.
• Completes required documents for all submissions specific to trials requiring Institutional Biosafety Committee (IBC) oversight.
• Completes required documents for all submissions specific to trials requiring FDA approval.
• Assists with training for new members of the Regulatory Affairs team.
• Serves as back up coverage during RAC absences.
• Collects documents and site regulatory communication for multi-center clinical trials

Additional Skills for RAC II

• Understanding of research standards as set forth by FDA, OHRP, UCH, UCD and NCI.

Salary and Benefits:
The salary range (or hiring range) for this position has been established at $43,830.

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

This position is not eligible for overtime compensation.

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:
Total Compensation Calculator:

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 Human Resources ADA Coordinator at .

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.

Minimum Requirements for RAC I

• Education: Bachelor's Degree in any field from an accredited college or university
• Work Experience: One or more years of professional medical, clinical and/or research experience.

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