Quality Assurance & Education Specialist
University of Colorado Denver l Anschutz Medical Campus
Office of Regulatory Compliance / Clinical Research Support Center
Job Title: Quality Assurance & Education Specialist
Position #703882 - Requisition #14387
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
The University of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.
Who We Are:
The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002.
The Office of Regulatory Compliance has an opening for a full-time University Staff (unclassified) Quality Assurance & Education Specialist position.
Jobs in this career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.
Professionals at the intermediate level are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field.
At the intermediate level, duties may be more limited in scope and are performed with guidance and direction from other professionals.
The UCD Clinical Research Support Center (CRSC) has been established in partnership with the Clinical and Translational Science Awards Center (CTSA) and within the Office of Regulatory Compliance/Clinical Research Administration. The mission of the Clinical Research Support Center is to assist investigators in the development, submission and approval of new protocols for review by the Colorado Multiple Institutional Review Board (COMIRB).
Examples of Work Performed:
- Works extensively with individuals in all areas of the University and UCD affiliates to promote collaboration with the Clinical Research Support Center to further the UCD's research mission
- Conducts compliance reviews and audits of human research studies being done at UCD Anschutz Medical Campus and Downtown Campus as per written policies and procedures to ensure all departments and divisions are in compliance with all applicable local and federal laws, regulations, polices and guideline
- Assures adherence to all research standards as set forth by the FDA, OHRP, GCP, ICH, UCD, UCH, NIH, COMIRB and other related federal agencies
- Communicates compliance review and audit findings both in person and in writing to the investigator and their research team
- Provides guidance documents, templates and advises on process improvement and best practices
- Under the direction of the Senior Research Facilitation Manager, assists in the development of educational tools and activities based on compliance review and audit findings
- Provides educational training to individual study teams, departments, and to the campus at-large through the Clinical Research Training & Education Program on topics including, but not limited to, human subjects' protection, informed consent, study documentation practices, and FDA regulated research
- Ensures that written procedures are followed in the evaluation of quality systems, processes, procedures and protocols
- Interprets regulatory requirements and makes recommendations to CSRC management regarding specific activities, training and resources required to support CSRC activities and mission
- Serves as an internal resource to address and resolve any questions or issues of a regulatory or quality assurance nature
- Remains informed of evolving regulatory revisions and guidelines that are relevant and ensure that the information is communicated to appropriate parties
- A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
- 1 year of professional level experience in clinical research
- Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
- Experience with academic center regulatory processes as related to clinical trials
- Experience working in an academic setting
- Experience conducting audits/quality assurance reviews
- Ability to communicate effectively, both in writing and orally
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
- Outstanding customer service skills
- Demonstrated commitment and leadership ability to advance diversity and inclusion
- Demonstrates advanced knowledge of FDA, OHRP, GCP, ICH regulations and sponsor operating procedures
- Knowledge of criteria that meet non-compliance including serious and/or continuing non-compliance
- Demonstrates ability to motivate research staff and foster good team working skills between CRSC, Affiliates, COMIRB, departments, CTRCs and research teams
- Demonstrates good communication skills (oral and written) with all sponsor companies, IRB, affiliates, CTRCs, research faculty, and staff
- Demonstrates accuracy in all details, and is able to record and report effectively
- Able to work independently; organize, plan and adjust work assignments while meeting deadlines
- Able to coordinate multiple projects of varying complexity simultaneously and work efficiently to meet department and investigator timelines
- Demonstrates ability to represent the institution at professional meetings
- Excellent leadership, team building, collaboration and communication skills are needed
- The hiring range for this position has been established at $47,000 to $55,000 and is commensurate with skills and experience
- This position is not eligible for overtime compensation
- Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
- Benefits: https://www.cu.edu/employee-services/benefits.
- Total Compensation Calculator: https://www.cu.edu/employee-services/total-compensation
- Please click here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx
- 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.
- 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.
Special Instructions to Applicants:Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references) Questions should be directed to: Amanda Childs - [email protected]
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Application Deadline: Review of applications will begin August 13th, 2018 and will continue until the position is filled.
Job Category: Research Services
Primary Location: Aurora
Department: U0001 -- Denver-Anschutz Administration - 60065 - ADM-VCR-Reg/Compliance Office
Posting Date: Aug 9, 2018
Closing Date: Ongoing
Posting Contact Name: Amanda Childs
Posting Contact Email: [email protected]
Position Number: 00703882