Position was renamed to Clinical Trial Manager

Managed close out of healthy volunteer PhI trial with Study team lead and supported start up planning for a PhII trial in C. difficile. Supported alliance management and led translational medicine collaborations and sample collection to support R&D drug candidate and disease declaration.

Support two therapeutic programs (Neuropathic Pain & ALS) and several ongoing studies (Phase I-II). Manage weekly development team meetings (prepare agenda, slides, and minutes) and present study enrolment and program updates to cross functional team members. Assisted in developing and maintaining program clinical development plans. Maintain eTMF and associated TMF trackers for assigned clinical program and studies. Conduct TMF QC and completeness reviews. Complete CDA and contract drafting for consultants. Organize advisory board meetings. Track ICF amendments, maintain SUSAR report tracking, and assist with study branding and template designs. Track invoices, budgets, site and CRO activities, IP release and shipment, patient enrollment, amendments and IRB submissions, internal document delivery timelines (protocols, amendments, IND AR, IB), annual goals. Experience with EDC development, CRF review, monitoring oversight, and CRO and vendor oversight. Skilled at mentoring, training, and overseeing Clinical Trial Assistants and other CTCs as necessary. Served as an active member in study development from protocol concept drafting, site feasibility and selection, through successful implementation of the trial. Assisted team in preparing initial regulatory document packages and annual updates. Experience with Global clinical trial regulations (FDA, PMDA, EMA, BfArM, AIFA,), and pediatric study planning.

Experience managing a large study portfolio with phase I, II, & III trials. Coordinate all study activities for assigned protocols (drug, device, imaging, and biorepository studies) including study start up, patient recruitment, enrollment, follow-up, and closeout. Ensure all study related activities are performed according to the sponsor’s protocols and in conjunction with FDA, GCP, and MEEI institutional regulations. Serve as a liaison between the sponsor, CRO, principal investigator, IRB, pharmacy, laboratory, reading centers, monitor, and subjects. Train medical students, fellows, and new coordinators on assigned protocols. Teach research specific computer programs. Centrifuge and ship biological samples. Conduct ECG, bp, and temperature.