Clinical Research Professional

Clinical Research Professional (Open Rank)

University of Colorado Anschutz Medical Campus

• Entry Professional
  • Assist with and oversee the day‑to‑day operations of clinical trials and studies
  • Obtain study subject's medical history and current medication information, review research protocol inclusion/exclusion criteria, and confirm eligibility of subject to participate in clinical trial
  • Perform informed consent process or ensure 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
• Intermediate Professional (all Entry responsibilities plus)
  • Independently master study materials, including 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 team leads, supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
  • Act as a primary coordinator on multiple trials/studies
  • Assist and train junior team members
• Senior Professional (all Intermediate responsibilities plus)
  • Assist with developing or developing protocol‑specific systems and documents including process flows, training manuals, SOPs and CRFs; maintain subject‑level documentation and prepare documents, equipment and/or supplies
  • Assist with identifying issues related to operational efficiency and share results with leadership
  • Collect information to determine feasibility, recruitment and retention strategies; employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
  • Serve as a resource and participate in study initiation and close‑out duties

This position will require occasional after‑hours and weekend work.

Hybrid

• 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

• Entry Professional
  • Bachelor's degree in biology, molecular biology, chemistry, genetics or related field
• Intermediate Professional
  • Bachelor's degree in biology, molecular biology, chemistry, genetics or related field
  • One (1) year professional level clinical research or related experience
• Senior Professional
  • Bachelor's degree in biology, molecular biology, chemistry, genetics or related field
  • Two (2) years clinical research or related experience
  • A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year‑for‑year basis.

• 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…