Regulatory Affairs Coordinator
University of Colorado Denver l Anschutz Medical Campus
University of Colorado Cancer Center
Regulatory Affairs Coordinator
Position # 00685408 - Requisition 12951
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
The University of Colorado Cancer Center has an opening for a full-time University Staff (unclassified) Regulatory Affairs Coordinator position.
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 15 hospitals nationwide by U.S. News and World Report and Children's Hospital Colorado is ranked 8th by the same organization in Pediatric Cancer Care. 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 261 researchers and physicians at three state universities and three clinical institutions, all working toward its vision to prevent and cure cancer while being a global model for patient care delivery, interdisciplinary research, and training.
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 Support Services), completion of Regulatory documents (Form 1572, Financial Disclosure forms, one page CVs), 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.
Examples of Work Performed
- 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.
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
Salary and Benefits
The beginning salary range for this position has been established at $41,411 and 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.
- Bachelor's Degree in any field from an accredited college or university.
- Substitution: Work experience in a related field may substitute for the degree on a year for year basis, but not for the specific experience.
- One or more years of medical, clinical and/or research experience.
- At least 1 year of Regulatory experience.
- Experience working with NCI, Industry, and Investigator Initiated clinical trials
- Experience working in an academic and/or medical environment
Knowledge, Skills, and Abilities
- Ability to problem solve and multi-task.
- Ability to work independently.
- Basic understanding of research specific to Human Subject Research protection, Good Clinical Practice and IRB requirements.
- Good command of the English language, both written and verbal.
- Proficient in Windows, MS Word, Excel, PowerPoint
- Excellent customer service skills
Special Instructions to Applicants:*Applications are accepted electronically ONLY at www.cu.edu/cu-careers * REQUIRED APPLICATION MATERIALS: 1). A cover letter/letter of application which specifically addresses the job requirements and outlines qualifications. 2) A current resume/CV. 3) List of 3-5 professional references. Questions should be directed to Sherri Wilke at Sherri.Wilke@ucdenver.edu
Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 5 references if you are referred to the Hiring Authority for an interview. We will notify you prior to contacting both on and off-list references.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:APPLICATION DEADLINE: Applications will be accepted until the position is filled, but full consideration will be given to complete applications received by March 26, 2018. Those who do not apply by March 26, 2018 may or may not be considered.
Job Category: Research Services
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 20066 - SOM-U of Colo Cancer Center
Posting Date: Mar 16, 2018
Closing Date: Ongoing
Posting Contact Name: Sherri Wilke
Posting Contact Email: Sherri.Wilke@ucdenver.edu
Position Number: 00685408