Research Services Clinical Sciences Professional (Open Rank: Entry – Intermediate)

University of Colorado Anschutz Medical Campus 

Department: Otolaryngology

Job Title: Research Services Clinical Sciences Professional (Open Rank: Entry – Intermediate)

Position #:00840143 – Requisition #:37738

Job Summary:

Duties (all levels):

• Assist with and oversee the day-to-day operations of clinical trials and research studies

• Serves as the Primary Coordinator on multiple trials/studies

• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities

• Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent documents are filed as required

• Interact with participants to gather study data and/or specimens

• Schedule participant participation in research clinical trials, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)

• Obtain study participants’ medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of participant to participate in the clinical trial

• Responsible for overseeing the secure handling, distribution, and tracking of gift cards, ensuring compliance with institutional policies and accurate record-keeping

Data Management

• Create/maintain research databases in REDCap, Excel, Sponsor’s Electronic Data Capture (EDC) system, and OnCore

• Collect, code, and analyze data obtained from research in an accurate and timely manner

Regulatory

• Assist faculty with writing research protocols

• Write informed consents/assents, IRB applications, and related documents in compliance with IRB requirements, and to manage the full approval process.

• 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

• Strong organizational and communication skills are essential, as the CRC collaborates closely with PIs, the Clinical Research Supervisor, clinical and research staff across multiple projects.

• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution

Duties Continued - (Intermediate level only):

• 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 managem