Clinical Project Manager
University of Colorado | CU Anschutz Medical Campus
- Serves as primary contact person for clinical research studies in start-up and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records. This may include the Food and Drug Administration (FDA).
- Works with regulatory specialist on study submission to PRMS and Research Administration Portal during start-up (this may include amendments prior to Site Initiation Visits).
- Completes OnCore specification and protocol sign-off during start-up. Acts as an interdepartmental liaison with UCH clinic staff (incl. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology). Plans and directs pre-study qualification visits with Sponsor and/or Contract Research Organization. Manages routing of confidentially agreements (CDA) with the Clinical Research Administrations Office (CRAO). Manages routing and reviews of contract trial agreements (CTA) with the Clinical Research Administrations Office (CRAO).
- Performs pre-reviews of all regulatory documents prior to IRB submission to promote quality study flow and ensure that all governing regulations are being adhered to. Participates in cost savings/productivity strategies to meet or improve the trial budgets.Assists in the development, implement and maintenance of University of Colorado
- Takes responsibility for meeting internal and external timelines.
- Attends clinical team meetings and SIV visits as necessary. CCTO Cancer Center Policies and Procedures in relation to conducting multiple clinical research trials and GCP.
- Manages all staff updates in OnCore in a timely and accurate manner for 1 to 3 disease sites during study start-up.
- Oversees OnCore calendar reviews and Medicare Analysis Reviews for 1-to 3 disease sites during start-up of a trial.
- Works with budget and regulatory specialist on amendment portal submissions for UCHealth during start-up.
- Submits and manages initial treatment plans through the UCHealth Beacon process and works with assigned RN for completion for 1 to 3 disease sites.
- Manages Internal Protocol Amendment Review forms or delegates responsibility as appropriate for 1 to 3 disease sites during start-up.
- Reviews budget and collaborates with budget specialist as needed during start-up.
- Helps facilitate the escalation plan with Contract Research Organizations and Sponsors as needed to keep the project moving.
- Adds new trials to disease site schemas
- Adds new trials to VIA oncology platform Updates OnCore fields, staff console, and internal trackers in a timely manner. Collaborates with Data Safety Monitoring Committee, Protocol Review Monitoring Committee, and Oncology Clinical Research Support Team on initiatives. Works with the Oncology Clinical Research Support Team staff on Investigator Initiated Trials reviewing protocol, IIT sign-off, and clinical toolkit. Assists investigators with miscellaneous tasks as applicable for start-up. Serves as role model to all Cancer Clinical Trial Office staff – remains in compliance with all training requirements, meets established deadlines, possesses a strong understanding of clinical research history, regulations, and ethics.Attends and participates in leadership and management courses for growth and skill development.Provides guidance regarding FDA and Good Clinical Practice regulation to clinical and investigator staff. Performs additional duties as assigned by senior project manager and/or clinical operations director.
- Bachelor’s degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment. Substitution: Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.A minimum of 4 years’ clinical research experience
- CCRC – Certified Clinical Research Coordinator
- CCRP – Certified Clinical Research Professional CCRA – Certified Clinical Research Associate
- Minimum of 2 years’ Oncology experience (clinical or research)
- Minimum of 5 years’ clinical, research or clinical research experience
- Experience working with Cancer Therapy Evaluation Program and PI initiated studies
- Experience working in an academic medical setting
- Experience in teaching, precepting and mentoring employees to clinical research
- Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task. Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials. Knowledge of research study budgets Understanding of computer systems (specifically MS Office Suite) and ability to work efficiently within various applications. Examples of work include creating treatment care plans for submission, utilizing workload management tools, and implementation or use of CTMS programs.Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions. Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminologyDemonstrates the quick ability to learn, interpret and master complex protocol information.Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology
Job Category: Research Services
Primary Location: Aurora
Posting Date: Apr 5, 2021
Unposting Date: Apr 18, 2021, 11:59:00 PM