Regulatory Affairs Coordinator
University of Colorado - School of Medicine
Professional Research Assistant
The University of Colorado, Department of Medicine, Division of Hematology has an opening for a Regulatory Affairs Coordinator to support our Hematology Clinical Trials Unit. This position will be full-time (1 FTE).
About the Program
The faculty of the Division of Hematology are responsible for teaching, clinical care and research in all aspects of Hematologic Disorders. Our division has physicians and advanced practice providers who are devoted primarily to clinical care and clinical research, physician scientists who divide their time between the lab and the clinic and scientists who spend their time focused primarily on laboratory research. Because we take such an integrated approach to the diagnosis, treatment and curing of blood disorders we are able to move treatments from the bench to the bedside in a significantly more timely fashion.
Our patients have access to clinical teams assembled specifically for each type of cancer - and all of these specialists are seen at one location, in one visit. Our medical teams meet regularly and work together to evaluate all cases, plan and deliver treatment, manage side effects and provide support for the entire treatment arc, including helping our patients stay healthy and tackle physical and emotional challenges after treatment.
The Division of Hematology also has the responsibility to promote clinical trials research efforts across the spectrum of hematology, and is committed to investigations involving non-malignant hematological disorders, as well as across all age spectrums.
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.
- Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado. This may include, but is not limited to, the following:
- Colorado Multiple Institutional Review Board (COMIRB)
- Protocol Review and Monitoring System (PRMS)
- Hospital Research Support Services (UCH-RSS)
- University of Colorado Hospital Biosafety Committee (IBC)
- University of Colorado Hospital Clinical Trials Research Center (CTRC)
- Writes clear and accurate subject informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations
- Completes and submits continuing reviews, amendments, and safety updates as needed
- Participates in Data Safety Monitoring Committee (DSMC) internal audits
- Updates database with regulatory submission and approval dates
Knowledge, Skills & Abilities
- Ability to problem solve and multi-task
- Ability to work independently
- Good command of the English language, both written and verbal
- Strong interpersonal and human relations skills
- Ability to work independently, identify and set priorities, and meet deadlines in a fast-paced work environment
Salary and Benefits:
Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.
The University of Colorado Denver 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 strongly supports the principle of diversity. 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 Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.
Education: BS or BA in any field
Experience: One or more years of clinical and/or research experience
Any combination of the above (A graduate degree can substitute for the work experience)
- Understanding of research standard as set forth by FDA, OHRP, UCH, UCD and NCI
- Excellent computer skills. Proficient in Windows, MS Word, Excel, Access, PowerPoint
- Experience: 3+ years research and/or regulatory experience
- Certification w/CCRC, CCRA, or RAC
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 11462
When applying, applicants must include:
- A letter of application which specifically addresses the job requirements and outlines qualifications
- A current Resume/CV
- The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please do not submit any of your application material (via email) to the job posting contact.
Job Category: Faculty
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 20164 - SOM-MED-BoneMarrow Transplant
Posting Date: Oct 19, 2017
Closing Date: Ongoing
Posting Contact Name: Lynette Brandon
Posting Contact Email: [email protected]
Position Number: 00050330