Regulatory Affairs Assistant
University of Colorado Denver l Anschutz Medical Campus
University of Colorado Cancer Center
Regulatory Affairs Assistant
Position # 00706187 - Requisition 12952
* 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.
The Cancer Center is looking to hire a full time Regulatory Affairs Assistant to participate in the implementation and compliance of clinical trials in the Cancer Clinical Trials Office (CCTO) at the University of Colorado Cancer Center.
Examples of Work Performed
- Assists Regulatory Affairs Coordinator (RAC) throughout the duration of multiple clinical trials. This may include protocol specific study staff tracking, assisting with the completion of accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado Cancer Center. The required regulatory bodies 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)
- University of Colorado Hospital Research Support Services (UCH-RSS)
- University of Colorado Hospital Biosafety Committee (IBC)
- University of Colorado Hospital General Clinical Research Center (GCRC)
- Work closely with multiple sponsors' web portals:
- Download all safety updates for PI review
- Download all amendments and ICF revisions
- Upload University approvals
- Schedule monitoring visits for assigned RACs
- Provide regulatory binders (paper or electronic versions) to sponsor monitors during their monitoring visits and audits
- Assist assigned RACs with audit preparation
- For cooperative group trials, download broadcasts from sponsor and disseminate to appropriate RAC(s)
- Process safety updates per COMIRB/WIRB policies
- May be responsible for revisions and updates to regulatory documents such as the 1572, financial disclosure forms, etc.
- Electronically compile lab verifications, CV's, licenses for monitoring visits and sponsors
- Miscellaneous filing, archiving and document gathering
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 hiring salary for this position is negotiable and commensurate with skills and experience. This position is 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.
- Two years of general clerical experience.
- Full time professional clerical experience in an academic, clinical or research environment
- Experience with human subject/clinical research
- Bachelor's Degree in any field
Knowledge, Skills, and Abilities
- Ability to problem solve and multi-task
- Ability to work as part of a team
- Excellent verbal and written communication skills
- Excellent computer skills (proficient in Windows, MS Word, Excel, PowerPoint)
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: Administrative Support and Related
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: 00706187