Assistant Research Professor/Clinical Research Operations Manager

University of Colorado • Aurora, CO

2d • Onsite

About The Position

The researcher provides organizational leadership, regulatory and operational oversight for a complex research portfolio for the Colorado Critical Care Research Group (C3RG) at the University of Colorado, Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM). As the Clinical Research Operations Manager, the person in this key role directs design, preparation, planning, implementation and review of sponsored and investigator-initiated research, ensuring compliance with institutional, local, federal and state standards and policies. This position oversees the implementation of clinical trials, guides and directs a team of clinical research coordinators, lab personnel, grants and regulatory staff. The incumbent provides daily management/supervision to the clinical research coordinators to promote enrollment, protocol and regulatory compliance, milestone completion, and exemplary conduct and generation of accurate and complete substantiated data of the clinical research activities. Incumbent assists investigators in developing strategic planning goals and initiatives for clinical research. The candidate in this role may work predominantly implementing team research objectives, as a sub-investigator, or work to advance their own independent research agenda over time. The candidate will co-develop a career development plan for their own professional growth, facilitated with department input and support.

Requirements

• Terminal degree, or PhD in research, healthcare or directly related field, finance, accounting, business, public health, public administration, social/behavioral sciences, physical sciences from an accredited institution.
• Five (5) or more years of relevant clinical research experience in and academic medical, research, pharmaceutical or CRO industry
• Prior data management experience.
• Five (5) or more year’s critical care clinical and research experience.

Nice To Haves

• Specific licensure may be required (e.g. Nurse Practitioner, Registered Nurse, CCRP, etc.)
• Nurse Practitioner (NP) licensure in the state of Colorado (active and unrestricted)
• Outstanding leadership skills within a large academic medical center conducting complex research.
• Strong knowledge of GCP, ICH guidelines, and FDA regulations
• Excellent clinical judgment and ability to make sound medical decisions within scope of practice
• Strong organizational, communication, and interpersonal skills with the ability to work collaboratively in a multidisciplinary research environment
• Ability to plan, implement, and coordinate financial and administrative activities across internal and external teams.

Responsibilities

• research implementation
• day-to-day leadership
• conduct and management of clinical trials
• grants and contracts solicitation and administration, grant/agreement preparation, review and negotiation
• regulatory compliance, human subject compliance
• budget creation, financial management, audit and procurement functions of the Moss/Burnham PACCM research lab.

Benefits

• Medical: Multiple plan options
• Dental: Multiple plan options
• Disability, Life, Vision
• Retirement 401(a) Plan: Employer contributes 10% of your gross pay
• Paid Time Off: Accruals over the year (based on percentage of time)
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 11/year
• Tuition Benefit: Employees have access to this benefit on all CU campuses
• ECO Pass: Reduced rate RTD Bus and light rail service

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree