Regulatory Affairs Coordinator
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
University of Colorado Denver l Anschutz Medical Campus
School of Medicine / Division of Gastroenterology & Hepatology
Regulatory Affairs Coordinator
Position #00703444 - Requisition #10519
The University of Colorado Division of Gastroenterology and Hepatology is seeking a full time, University Staff (non-classified) Regulatory Affairs Coordinator. This position is responsible for providing central management and regulatory oversight for clinical trials and investigator initiated studies for division of gastroenterology and hepatology. The regulatory affairs coordinator will work closely with Principal Investigators, Research Development Manager, the department's administration team, and other departments and centers on campus and hospitals and clinics. The regulatory affairs coordinator will provide support and leadership for studies that may involve industry-sponsored Phase I, II, III, IV clinical trials and investigator initiated studies. The research affairs coordinator will ensure accurate progress of clinical research from the planning and approval stages through study completion and post-study closure.
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 boards.
*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 sponsored studies within the required 90 days period.
*Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the division of Gastroenterology and Hepatology. This may include, but is not limited to, the following:
I. Colorado Multiple Institutional Review Board (COMIRB).
II. Western Institutional Review Board (WIRB).
III. NCI Central Institutional Review Board (CIRB).
IV. Protocol Review and Monitoring System (PRMS).
V. Hospital Research Support Services (UCH-RSS).
VI. University of Colorado Hospital Clinical Trials Office (CTO)
VII. National Institute of Health (NIH)
VIII. Hospital Research Review Committee (HRRC)
*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 VA Medical Center.
*Updates OnCore with regulatory documents and dates.
*Prepares the site for audit inspections with either the Institutions (COMIRB), Sponsor or the FDA
*Participates in Data Safety Monitoring Committee (DSMC) internal audits
*Serves as a liaison and information resource to University of Colorado Denver (UCD) faculty and staff by advising them on all federal requirements and university policies for approval of research with humans.
*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
*Performs internal audits on regulatory documents to ensure the proper maintenance and accuracy of protocol files and data entry according to federal regulatory requirements and COMIRB SOPs/guidelines to ensure the timeliness, correctness and compliance of the studies
*Drafts IRB applications for COMIRB. Requires the ability to read and interpret a research protocol and an understanding of human subjects and HIPAA-protected data.
*Serves a key role on Divisional Administrative Research Team (DART) to ensure compliance and awareness of all current and pending clinical trial activity for the division.
*Other duties as assigned by the Research Development Manager
PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.
Salary and Benefits:
The hiring salary for this position is $48,675 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 from an accredited institution
*One year of clinical and/or research experience
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis.
*One 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.
Knowledge, Skills, and Abilities
*Ability to solve problems and multi-task.
*Ability to work independently with minimal supervision.
*Basic understanding of research specific to Human Subject Research protection, Good Clinical Practice, and IRB requirements.
*Organizes and prioritizes numerous tasks and completes them under time constraints.
*Strong interpersonal skills and excellent oral and written communication skills
*Intermediate to expert user of standard computer systems and software programs, including MS Office (Excel, Word, Outlook, 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 Sandra Boimbo at Sandra.Boimbo@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 3-5 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 and will continue until the position is filled.
Job Category: Research Services
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 20189 - SOM-MED-Gastroenterology
Posting Date: Aug 1, 2017
Closing Date: Ongoing
Posting Contact Name: Shannon Onken
Posting Contact Email: Shannon.email@example.com
Position Number: 00703444