Head and Neck Clinical Research Coordinator

Head and Neck Clinical Research Coordinator

University of Colorado Anschutz Medical Campus

Department: Cancer Center – CCTO (Head & Neck Team)

Working Title: Head and Neck Clinical Research Coordinator

Position #:  – Requisition #38414

Key Responsibilities:

• Assist with and oversee the day‑to‑day operations of clinical trials and studies
• Abstract and record all research subject data onto protocol‑specific Case Report Forms (CRFs) and into the clinical trials database in an accurate and timely fashion
• 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 or ensure proper documentation of the informed consent process
• Interview prospective subjects for a variety of research clinical trials and 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)
• Collaborate with other clinical research team members, investigators, and hospital staff to ensure tests and procedures required by research protocols are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms, research drug administration, protocol‑specific tests); follow up on missing or discrepant data
• Meet with monitors to respond to any questions of data validity and correct/revise data as appropriate; respond to queries from sponsor
• Adhere to research regulatory standards
• Maintain detailed records of studies, including Patient Source Document Binder, to ensure compliance with FDA, study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
• Assist with sponsor, Data Safety Monitoring, and FDA audits and responses
• Participate in subject recruitment efforts, including communicating with patients expressing 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 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 with developing or develop protocol‑specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (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
• 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

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

• Bachelor's degree in any field

• Bachelor's degree in any field
• A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year‑for‑year basis
• One (1) year of professional clinical research experience and/or…