Clinical Sciences Entry Professional

University of Colorado

1d•Hybrid

About The Position

The University of Colorado School of Medicine is seeking a Clinical Sciences Entry Professional to join our Type 1 Diabetes (T1D) psychology clinical research team at the Barbara Davis Center for Diabetes and their colleagues in advancing groundbreaking research and improving patient outcomes. Working alongside a multidisciplinary team of psychologists, physicians, researchers and behavioral health professionals in psychology and related fields, you will help advance studies aimed at improving prevention, treatment, and long-term outcomes for children, adolescents, and young adults living with diabetes and other endocrinology conditions.

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.
Applicants must meet minimum qualifications at the time of hire.
Excellent interpersonal skills
Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
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
Demonstrated commitment and leadership ability to advance diversity and inclusion
Knowledge of basic human anatomy, physiology medical terminology
Ability to interpret and master complex research protocol information

Nice To Haves

Bachelor’s degree in psychology or other health related field
Clinical research or related experience
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

Responsibilities

Assist with and oversee the day-to-day operations of clinical trials and studies
Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Collect, code, and analyze data obtained from research in an accurate and timely manner
Adhere to research regulatory standards
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
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
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
Assist senior staff and Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
Independently prepare and submit study start-up tasks for single and multisite clinical trial studies
Draft regulatory reports for Institutional Review Board, study sponsors, and Data Safety/Independent Monitoring Committees
Prepare study papers, including writing independent portions of articles for peer-reviewed journal submissions