COMMUNICATIONS: The CRT is expected to facilitate communications between study sponsors, research volunteers, investigators, regulatory personnel, and other key contributors such as the University of Michigan Clinical Trials Support Unit (CTSU). The communications will include, but are not limited to scheduling appointments, meeting with investigators, interfacing with the regulatory and financial authorities, working closely with study monitors, and resolving issues that invariably arise.
REGULATORY COMPLIANCE: The CRT is expected to ensure that all research is conducted safely and according to protocol. This includes maintenance of study source documents and essential regulatory documents; reporting of adverse events; understanding of good clinical practice (GCP); and ensuring compliance with federal, state, and sponsor policies.
PATIENT INTERACTION: The CRT will help recruitment efforts by contacting patients of interest on the phone or meeting with them in clinic to explain the study. During enrollment, along with study investigators, CRTs will help evaluate subjects for inclusion/exclusion criteria and obtain patient consent. At study visits, CRTs will collect past medical history, concomittant medications, and adverse events, and then take research patients through the protocol schedule of activities for each visit. CRTS will perform majority of the required testing (visual acuity, contrast sensitivity, visual fields, vital signs, EKGs, blood draws, etc.) and scribe for our physicians while they perform eye exams on patients.
DATA: CRTs will input the data collected into case report forms and/or electronic data capture systems, maintain studies in the OnCore clinical trial management system, and resolve queries.
PROTOCOL SPECIFIC NEEDS: In addition to the broad technical skills needed in nearly every ophthalmic clinical study (e.g. visual acuity, refraction, intraocular pressure, etc.), each study often has unique needs. The CRT is expected to possess a willingness to learn protocol specific requirements. Many of our clinical trials require ordering and handling investigational product.
OTHER: Clinical research regulations and best practices are frequently changing. The CRT is expected to incorporate these changes into the work flow as they occur. In addition, the CRT will need to become proficient with phlebotomy and acquire various certifications pertinent to the position (Ex: PEERRS, CITI GCP)