Regulatory Affairs Coordinator

Location
Aurora, CO
Posted
Mar 28, 2017
Institution Type
Four-Year Institution




* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

University of Colorado Denver l Anschutz Medical Campus

School of Medicine / CU Cancer Center

Regulatory Affairs Coordinator

Position #00680338 - Requisition 07576

The CU 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.

The Cancer Center Clinical Trials Office (CCTO) is looking to hire a full time Regulatory Affairs coordinator who will be responsible for providing central management and regulatory oversight for clinical trials at the CU Cancer Center.



Examples of Work Performed

  1. 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.
  2. Writes clear and accurate consent/ HIPAA documents.
  3. Completes consents, applications and other required forms as per the applicable Institutional Review Board (IRB).
  4. Submits, tracks and processes protocol amendments for National Clinical Trials Network (NCTN) studies within the required 90 day period.
  5. 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)

6. Completes and submits continuing reviews, amendments, and other protocol-

specific documents.

7. Completes and submits accurate federal forms, consents, HIPAA Authorizations, and obtains required approvals specific to the Denver VA medical Center.

8. Navigates applicable NCTN websites. This may include Clinical Trials Support Unit (CTSU), Southwest Oncology Group (SWOG) and NRG Oncology (NSABP, RTOG, GOG).

9. Updates OnCore with regulatory documents and dates.

Salary is commensurate with skills and experience. The beginning of the salary range for this position is $41,374. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/es.

Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

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.


Qualifications

Minimum Requirements

• Bachelor's Degree in any field from an accredited college or university.

• One (1) year of clinical and/or research experience.

Substitution: Work experience in a related field may substitute for the degree on a year-for-year basis.

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, in both written and verbal form. • Proficient in Windows, as well as MS Word, Excel, PowerPoint.

Preferred Qualifications

• One (1) or more years of regulatory experience.

• Experience working with NCI, Industry and Investigator initiated clinical trials.

• Experience working in an academic and/or medical environment.

• Experience working with University of Colorado Systems.


Special Instructions to Applicants:*Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Please do not e-mail materials to job posting contact. * REQUIRED APPLICATION MATERIALS: 1). A cover letter which specifically addresses the job requirements and outlines qualifications 2). A current resume/CV 3). List of 5 professional references. Questions should be directed to Lisa LaPoint at lisa.lapoint@ucdenver.edu

Reference checks are a standard step in our hiring process. You will 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:Review of applications will begin immediately. Applications will be accepted until the position is filled, but full consideration will be given to complete applications received by May 21, 2017. Those who do not apply by May 21, 2017 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

Schedule: Full-time

Posting Date: May 19, 2017

Closing Date: Ongoing

Posting Contact Name: Lisa LaPoint

Posting Contact Email: lisa.lapoint@ucdenver.edu

Position Number: 00680338

PI97306256