Clinical Research Professional (Open Rank: Intermediate - Senior)
University of ColoradoAbout the role
Description
University of Colorado Anschutz Medical Campus
Department: Ophthalmology
Job Title: Clinical Research Professional (Open Rank: Intermediate - Senior)
Position #00836051 – Requisition # 37038
Job Summary:
The Department of Ophthalmology participates in multiple sponsored and investigator-initiated clinical trials for diseases and disorders of the eye. Our involvement in a wide variety of studies, including surveys, observational, interventional, device, and drug trials, contributes valuable knowledge for the ophthalmic community at large.
Key Responsibilities / Duties:
Intermediate –
- 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
- 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 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 – all of the above, plus:
- Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
- Assist with identifying issues related to operational efficiency and shares results with leadership<
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