• Responsible for the collection and review of regulatory documents for accuracy and completeness at study start up as well as throughout study.• Communicates with sites on document updates and corrections•Liaises with Site Managers on trial documents and study site readiness.•Reviews Informed Consent Forms for compliance.•Co-monitoring experience on-site.•Experience with trip reports, EDC, and review of eCRFs.•Initiates sites in CTMS as well as makes updates and ensures accuracy of sites within the system (Medidata Champion).•Tracks status of documents to reflect receipt and approval.•Partners with trial managers to ensure expeditious review of regulatory documents for drug ship approval.•Assembles Trial Center File Binder and study start-up materials for new sites.•Maintains and updates CTSRS contact information to ensure appropriate SUA distribution.•Maintains Trial Master File (IF) and performs periodic reconciliation of the files (Veeva Vault eTMF Champion)•Processes, tracks, and distributes documents as required for protocol amendments.•Process Expert and primary department contact for the Intralinks electronic safety reporting system.

• Experience with studies in start-up, conduct, and close-out phases• Therapeutic areas include oncology and neuroscience, phases I/II. Number of patients ranging from 60-240 in up to 50 sites worldwide• Collection and review of regulatory documents (Protocol, IB, 1572s, CVs, FIDs A/B) for quality, accuracy and compliance with regulatory requirements• Tracking feasibility status• Planning and facilitating study meetings (Investigator, CRO, CRA, and Coordinator)• Managing central IRB submissions • TMF filing and quarterly reviews, updating newsletters, and tracking Good Clinical Practice compliance• Managing the creation, storage, and shipping of supplies to sites globally• Collecting Local Lab Normal Ranges• Initiating site level approval for drug shipments• Creating of study manuals and regulatory binders• Maintaining study specific logs/trackers/contact lists and distributing to team/vendors/sites• Mentoring new CSAs in the performing of daily tasks