About the role

Clinical Research Program Director overseeing clinical research operations at the University of Colorado. Responsible for managing studies, compliance, and team leadership in a hybrid role.

Responsibilities

Responsible for the management of all clinical research operations through the department, including pharmaceutical-based trials, investigator-initiated research and trials, bio-banking, and internal clinical research.
Key role in developing and executing broad research goals with department leadership.
Establishing best-in-class operational procedures, growing patient and study enrollment, and mapping out the strategic priorities for clinical research.
Management of all departmental human-subject research and the study coordinator teams.
Administration of the internal and external regulatory processes.
Support of finance-related activities in partnership with the department finance team.
Functioning as a trainer for study coordinators and backup coordinator as needed.
Project development including editing protocols, writing consent forms and subject materials, and interpretation of protocols.
Analysis of results and contribution to publications.
Local and central IRB submissions, maintaining clinical trial records, FDA submissions, and acting as a liaison between industry, grants and contracts, principal investigators, and the department administrator.

Bachelor’s degree in any field
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
An advanced degree (Masters or PhD) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
Six (6) years of clinical research or related experience
Two (2) years management experience in a clinical research setting
Master’s degree in a science or health related field (preferred)
Four (4)- Five (5) years supervisory or management experience in a clinical research setting (preferred)
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) (preferred)
Three or more years of clinical research experience in an ophthalmic practice setting (preferred)
Certification as a Certified Ophthalmic Technician (COT) or higher with a minimum of 2 years of relevant ophthalmic medical experience may be substituted for degree (preferred)
Classroom and medical experience in ophthalmology to include refraction, tonometry, ETDRS vision testing, pupillary assessment, and ability to perform basic slit lamp exam is required (preferred)
Current Clinical Research Certification (CCRC, CCRA, CCRP) or meets criteria to sit for exam within one year (preferred).