Research Services Professional (Open Rank – Entry to Senior Level)

University of Colorado•Aurora, CO

8h•Hybrid

About The Position

The Division of Plastic and Reconstructive Surgery is seeking a motivated, passionate and self-driven individual for a full time Research Services Professional position to assist faculty and residents with clinical trials research. This position has the opportunity to be hybrid depending on the needs of the division and will be involved in research both at Children’s Hospital Colorado, the University of Colorado Hospital and the University of Colorado. Jobs in this career family provide direct professional support of research activities. Functions include grant/agreement preparation, regulatory compliance, sponsor communication, and human subject compliance. At the entry level, duties are limited in scope and are performed with guidance and direction from other professionals and are performed in a training and development capacity. At the intermediate level, duties may be more limited in scope and are performed with guidance and direction from other professionals. Senior Professionals are responsible for exercising discretion, analytical skills, personal accountability, and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying, and sharing knowledge directly related to a professional field. Work is performed fully independently.

Requirements

Applicants must meet minimum qualifications at the time of hire.
Entry Level: A bachelor’s degree in Biology, Public Health or related field from an accredited institution
Intermediate Level: A bachelor’s degree in Biology, Public Health or related field from an accredited institution 1 year of professional level experience in a clinical research and academic setting.
Senior Level: A bachelor’s degree in Biology, Public Health or related field from an accredited institution 2 years of professional level experience in a clinical research position within an academic setting.

Nice To Haves

Experience in academic setting
Experience with Electronic Data Capturing Systems
Experience in OnCore, EPIC and REDCap
Experience in SAS
Exceptional interpersonal communications

Responsibilities

Coordinate the day-to-day operations of research studies for Division which includes but is not limited to the following :
Study Coordination (50%) Review protocols and confirm participant eligibility (inclusion/exclusion criteria). Coordinate recruitment, pre-screening/screening, enrollment tracking, and participant education/interviews. Conduct and document informed consent; ensure required filing and compliance. Assess study feasibility and optimize recruitment/retention strategies through data collection and process improvement. Develop and maintain protocol-required study systems and documentation (SOPs, CRFs, process flows, source documents), and coordinate regulatory submissions/maintenance (IRB, CDAs, required filings).
Data and Database Management (30%) Manage research databases (design, build, organize, maintain, and retrieve study data). Enter and maintain data in Electronic Data Capture (EDC) systems and extract required data from the EHR (e.g., Epic). Maintain complete, compliant study records in accordance with protocols, departmental/clinical SOPs, and regulatory requirements. Support investigators with literature reviews, protocol development (including data management plans), and IRB submissions/ongoing maintenance. Assist with project planning, data interpretation, team presentations, and serve as a liaison/resource for sponsors and external sites through study start-up and close-out.
Team Collaboration (20%) Communicate and collaborate with various colleagues (e.g., principal investigator, clinicians, medical staff, sponsors, contract research organizations (CROs), other research staff, finance and billing professionals, and regulatory team) at various stages of each study assigned. The research services professional is responsible for providing excellent customer service to both internal and external stakeholders by presenting a positive image of the department and University. Oversee trainees involved in division research projects such as ensuring the completion of required research trainings and proper completion of research tasks assigned to the trainees. Assist residents and medical students with abstract and manuscript writing. Communicate the research findings with the team during meetings when required.