Research Services Intermediate – Senior Professional

University of Colorado Anschutz

Department: Ophthalmology

Job Title: Research Services Intermediate – Senior Professional

Position #  – Requisition #40466

The Department of Ophthalmology has an opening for 1.0 FTE clinical intermediate – senior professional to support our Cornea division. The successful candidate will coordinate clinical studies, assist with adherence to IRB/regulatory requirements, enroll and correspond with study participants, act as liaison to industry sponsors of research studies, clinical research organizations, the Federal Drug Administration, and other participating centers, maintain study databases and files, create and monitor study budgets and generate and process invoices.

Provide ophthalmic assistance to the Cornea division faculty, fellow and rotating resident, providing ancillary screening and testing as necessary.

• 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.
• 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.

• 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 shares 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.

Onsite – this role is expected to work onsite and is located in City, State.

Minimum Qualifications:

• Bachelor's degree from an accredited institution and 1 year of professional experience in clinical research. A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.

• Bachelor's degree from an accredited institution and 2 years of professional experience in clinical research. A combination of education and related…