OCRST Regulatory Affairs Coordinator
University of Colorado Denver l Anschutz Medical Campus
University of Colorado Cancer Center
OCRST Regulatory Affairs Coordinator
Position # 00626268 - Requisition 12367
* 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) Oncology Clinical Research Support Team (OCRST) 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:
The Cancer Center Oncology Clinical Research Support Team (OCRST) is responsible for providing central management and oversight for Investigator-Initiated clinical trials at the CU Cancer Center. The Regulatory Affairs Coordinator (RAC) works with investigators and OCRST members in the development and implementation of investigator-initiated clinical trials. This position is responsible for completing regulatory start up and maintenance tasks. The position will also be responsible for submissions to the FDA for IND applications as required for investigator-initiated trials. 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
Examples of Work Performed:
- Serves as regulatory contact person for Investigator-Initiated clinical research studies and meets with Principal Investigators as well as in-house staff 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).
- Assists in the completion of initial Institutional Biosafety (IBC) applications as needed.
- 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:
- Food and Drug Administration (FDA)
- Office of Human Research Protections (OHRP)
- Colorado Multiple Institutional Review Board (COMIRB)
- NCI Clinical Trials Evaluation Program (CTEP)
- Protocol Review and Monitoring System (PRMS)
- Hospital Research Support Services (UCH-RSS)
- University of Colorado Clinical Research Support Center (CRSC)
- Completes and submits continuing reviews, amendments, and other protocol-specific documents.
- Maintains regulatory documentation for Investigator-Initiated research studies for review by monitors and auditors including preparation for monitoring/auditing visits and resolution of queries.
- Completes and submits accurate federal forms, consents, HIPAA Authorizations, and obtains required approvals specific to the Denver VA medical Center as necessary.
- Updates OnCore with regulatory documents and dates.
- 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.
- Assist principal investigators and clinical project manager(s) in the development of the protocol and subsequent amendments for investigator initiated trials to ensure standardization and adherence to University and Cancer Center, FDA and GCP policies and guidelines for Investigator-Initiated and multi-center trials
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 starts 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.
- Education: Bachelor's Degree focused in biological, medical science or business such as Nursing, Biology, Public Health, Business Administration or related fields of study.
- Substitution: Work experience in a related field can substitute for the Bachelor's degree on a year for year basis, but not for the specific experience. Additionally, an Associate's Degree plus 2 additional years of related work experience will also substitute for the Bachelor's degree.
- Experience: Two (2) or more years of clinical or regulatory research experience
- Two (2) years oncology research and/or academic regulatory experience.
- Experience with submissions to IRBs, and/or the FDA for IND or IDE.
- Experience working with Investigator-Initiated clinical trials
- Experience handling and prioritizing detailed tasks and meeting deadlines.
- General understanding of Anatomy, Physiology, and medical terminology a plus
Knowledge, Skills, and Abilities
- Ability to problem solve and multi-task in high volume setting
- Understanding of research standards as set forth by FDA, OHRP, UCH, UCD and NCI.
- Ability to work independently.
- Good command of the English language, both written and verbal.
- 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 Tiffany Cull at Tiffany.Cull@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 January 28.2018. Those who do not apply by January 28, 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: Jan 18, 2018
Closing Date: Ongoing
Posting Contact Name: Tiffany Cull
Posting Contact Email: Tiffany.Cull@ucdenver.edu
Position Number: 00626268