Clinical Sciences Program Director

Clinical Sciences Program Director

University of Colorado Anschutz Medical Campus

Department:
Ophthalmology

• Serves as administrative lead for clinical research.
• Work with DFA, clinical research manager and clinical trials finance coordinator to monitor and execute finance duties and assist in the long term strategy for sustaining clinical research in the department
• Provide oversight, direction and leadership for all clinical research operations within the department
• Hire, train, supervise, coach and direct team members
• Monitor, manage and deploy clinical research resources and FTE to department faculty and actively assess growth needs for personnel with in unit
• Provide oversight of Good Clinical Practice (GCP) in all studies
• Develop program/project goals and communicate goals and outcomes with a variety of stakeholders
• Participate in tactical and strategic program/project development and planning
• Participate in program/project budget development processes, including grant writing and submission processes, and regularly reviews to ensure alignment
• Lead and participate in program/project start up and close out functions

Hybrid

• Medical:
  Multiple plan options
• Dental:
  Multiple plan options
• Additional Insurance:
  Disability, Life, Vision
• Retirement 401(a) Plan:
  Employer contributes 10% of your gross pay
• Paid Time Off:
  Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 10/year
• Tuition Benefit:
  Employees have access to this benefit on all CU campuses
• ECO Pass:
  Reduced rate RTD Bus and light rail service

• 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
• Four (4)- Five (5) years supervisory or management experience in a clinical research setting
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Three or more years of clinical research experience in an ophthalmic practice setting.
• 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
• 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.
• Current Clinical Research Certification (CCRC, CCRA, CCRP) or meets criteria to sit for exam within one year.

• A business acumen with a strategic ability
• Excellent organizational and leadership skills
• An analytical mindset with great problem-solving abilities
• Ability to set goals, motivate team members to achieve results
• Knowledge of supervisory techniques, management principles, and organizational leadership
• Expert knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
• 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
• Knowledge of basic human anatomy, physiology medical terminology
• Ability to interpret and master complex research protocol information

The Department of Ophthalmology seeks a full-time Clinical Research Program Director. The position is 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. This position will play a 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.

Main components of the job include
1) management of all departmental human-subject research, and the study coordinator teams,
2) administration of the internal and external regulatory processes,
3) support of finance-related activities in partnership with the department finance team, and
4) functioning as a trainer for study coordinators and backup coordinator as needed. Tasks include project development such as editing protocols, writing consent forms and subject materials, and interpretation of protocols for the preparation of source documents, analysis of results and contribution to publications. Regulatory tasks include local and central IRB submissions, maintaining clinical…