Research Services Clinical Sciences Program Manager

University of Colorado•Colorado Springs, CO

9d•$70,446 - $94,398•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in any field
Four (4) years clinical research or related experience
Strong project management skills and experience within a complex and diverse environment
Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
Demonstration of strong analytical and problem-solving skills
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

Nice To Haves

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 (e.g. EMR or EHR and data management systems)
Experience developing and managing documents for Institutional Review Board (IRB) submissions
Experience with Department of War Office of Human Research Oversight (OHRO) and National Institutes of Health (NIH) regulatory requirements and reporting

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