Research Services Clinical Sciences Program Manager

Job Summary:

The University of Colorado, Anschutz Medical Campus, Department of Emergency Medicine is currently seeking applications for a Research Services Clinical Sciences Program Manager. This is a full-time, University Staff (non-classified) position for the Airway, Trauma, Lung injury, and Sepsis (ATLAS) Research Program.

Research Services Clinical Sciences Program Managers perform clinical and research-related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Research Services Clinical Sciences Program Managers independently manage clinical research programs, perform clinical research project management functions and/or supervise clinical research teams of 2 or more FTE. This position will work closely with lead project coordinators, Principal Investigators (PIs), and ATLAS Leadership.

Key Responsibilities:

• Supervise research staff and coordinators.

• Provide leadership, direction, coaching, and performance management to professional staff.

• Develop protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies

• May perform supervision and management responsibilities for a team of 2 or more professionals. Duties include, but are not limited to, recruitment, supervision, and performance management responsibilities

• Manage project timelines, deliverables, and resources.

• Develop program/project goals and communicate goals and outcomes with a variety of stakeholders

• Participate in tactical and strategic program/project development and planning

• Coordinate site visits and other meetings with key stakeholders

• Develop and implement community outreach and engagement initiatives

• Assist with and oversee the day-to-day operations of clinical trials and studies, when needed

• May perform duties and responsibilities of Clinic Research Professionals when necessary

• Ensure compliance with FDA, IRB, and institutional requirements.

• Develop, review, maintain regulatory and other program/project documentation

• Ensure program/project compliance with Food and Drug Administration (FDA) and other regulatory bodies

• Support study activation, implementation, and closeout activities.

• Liaise and coordinate with a variety of program/project stakeholders including, but not limited to, program/project sponsors, regulatory agents, pharmaceutical representatives, and clinic/hospital staff

• Develop and maintain a variety of reports and communicate and present data to stakeholders

This description is a summary only and describes the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business needs. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location:

Hybrid – this role is eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings.

Why Join Us:

This is an in-person position within the ATLAS Research Program, which offers a unique career and growth opportunity to serve as an integral member of a highly productive, collaborative, and vibrant research group conducting impactful health research in the care of acutely ill and injured patients. The diverse and complex patient population provides a rich learning environment and opportunities to expand the candidate's skillset across several research projects (including clinical trials and observational trials). The candidate will also be exposed to a like-minded research community to help enrich skills and enhance career growth. The ATLAS Research Program aims to advance solutions to the greatest challenges in acute care by leading transformative clinical trials. We are interested in candidates that have/want a direct connection to advancing medical knowledge and evidence-based care that can impact the lives of patients.

Outside the ATLAS Research Program environment, the candidate will be part of the larger University of Colorado Anschutz Medical Campus community. CU Anschutz is a prestigious public education, clinical and research academic institution serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $650 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care.

The University of Colorado 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. The University offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• 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

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications (pre-clinical/wet lab experience does not apply):

• Bachelor’s degree in any field

• Four (4) years clinical research or related experience

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Bachelor’s degree in science or health related field

• 2+ years of supervisory and team leadership

• Five (5) years clinical research or related experience

• Prior experience providing program and/or project management duties in a clinical research setting

• Experience with electronic data capture systems