Research Services Program Manager

University of Colorado

12d•$68,394 - $86,998•Hybrid

About The Position

The University of Colorado Denver | Anschutz Medical Campus| Department of Emergency Medicine, is currently seeking applications for a Research Services Program Manager. This is a full-time, University Staff (non-classified) position, for the Injury Generated by Burn and Frostbite (IGNITE) lab and the Airway, Trauma, Lung Injury, and Sepsis (ATLAS) lab. The Department of Emergency Medicine, the IGNITE lab and ATLAS lab seek motivated applicants for the position of Research Services Program Manager. This role will engage patients, families, and clinical staff at the University of Colorado Hospital, manage study start-up and documentation for clinical trials, assist with grant preparation and submission, technical reporting, and regulatory activities, as well as collaborate with clinical and research teams working to improve care of critically ill burn and frostbite patients. The projects focus on patients in the Emergency Department and Burn Intensive Care Units with critically injured burn and frostbite patients. The ideal candidate will have experience within research (clinical or laboratory), collaborate effectively on multidisciplinary teams, and be highly detail oriented.

Requirements

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 Doctorate) 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.
Four (4) years of clinical research or related experience
Applicants must meet minimum qualifications at the time of hire.

Nice To Haves

Bachelor’s degree in science or health related field
Five (5) years of 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 with industry-sponsored clinical trials
Experience with managing multi-center clinical trials
Project management certification
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

Responsibilities

Assist with and oversee the day-to-day operations of clinical trials and studies
Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
Ensure that the necessary supplies and equipment for studies are in stock and in working order
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
Oversee the preparation of orders by physicians to ensure that protocol compliance is maintained. Independently review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document and report all findings to physician and care team
Assist with budget creation and grant submissions
DOD regulatory and technical reporting submissions
Manage and conduct moderately complex research activities that are part of a larger project from initiation to close.
Create complex data management and tracking tools (REDCap, Excel) to support tracking of project/recruitment activities.
Oversee student worker(s) or junior PRAs as it relates to a specific project.
Participate in instrument creation (REDCap) and/or analytical structures as appropriate to the project.
Collect study data via complex patient visits, surveys, observations, or focus groups. Provide leadership in data collection to other PRAs and students.
Participate in audits, monitoring visits, and quality control checks of data collection, equipment maintenance, and study procedures.
Help develop study findings for presentation to team and external audiences.
May lead publication development (abstract/manuscript)
Help with budget management/tracking (under direction of PM/PI)
Lead manuscript preparation for publication or presentation in scientific forums.
Work with members of the UCD and UCHealth community as needed to set up labs, participant visits, and access shared University resources.
Manage study participant incentive program with the assistance of procurement.