Tyler Mullen Email and Phone Number

Research Coordinator II at Cleveland Clinic

● Clinical trial start up including regulatory documents, informed consent, IRB applications, recruiting patients, overseeing study patient visits, and entering study data after completed visits● Maintenance of regulatory binders including submitting updates to all regulatory documents and receiving approval of new regulatory documents● Prepare for site initiation visits, monitoring visits, and audits● Document serious adverse events to sponsor within 24 hours notice● Submit continuing renewals for keep studies open● Submit study closed applications to close studies● Completes IRB submissions with internal IRB● Works with Sponsor IRBs to comply with internal IRB● Assures compliance with patients on clinical trial● Works with the Principal Investigator to coordinate all aspects of implementation ofassigned clinical trials● Screens participants for eligibility and recruitment● Educates participants on study requirements● Completes informed consent process with clinical trial patient● Schedules all study related appointments, including outside departments● Knowledge of all assigned protocols in accordance with GCP● Ensures documentation is compliant with Sponsor, SOP, and regulatory agenciesguidelines● Establish and maintain communication with Investigator, Sponsor, and internalconstituents● Extracts clinical study data from source documentation● Inputs data in several clinical databases for all working protocols● Coordinates with Sponsor, PI, and Study Team on clinical trial activation● Resolves any queries from Site Monitors or Database Managers● Performs other related duties

● Read ophthalmic images for multi-center clinical trials using image analysis software and imaging standards● Provided standardized, reproducible measurements of clinical ophthalmic findings● Assessed quality of all images read● Assessed patient eligibility for clinical sites● Prepared for monitoring visits and audits with team members● Helped create Work Instructions for team● Assisted in any additional duties