Good Shepherds Clinical Research
September 2017 — Present
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Summary A highly experienced Clinical Trial Manager with considerable U.S. and Global experience including Several years of progressive, well-rounded industry experience as a Study Coordinator, Site Manager, Clinical Trial Manager, and Consultant/ Contractor within Site, SMO, CRO We have set up a highly qualified tea...
Assist in the scheduling of all study unit staff.
•Review all study protocols and assist in the execution of protocols review meeting for study monitors
•Supervise study monitors and oversee their performance in the execution of study procedures. Function as a study monitor as necessary to •ensure coverage of scheduled studies.
•Supervise and/or execute the set up for each study.
•Execute the inventory and order process of all medical supplies and supplies used to operate the facility.
•Schedule and supervise specimen shipment. Execute paperwork required for shipment.
•Supervise the labeling of specimen containers and the Labeling Technician
•Oversee specimen collection, specimen storage, and specimen paperwork. .
•Maintain emergency cart, required inspections, and validation of all study unit equipment.
•Participate in the QA execution and review of study documents (i.e. Consent forms, study reports).
•Insure proper documentation of all procedures (i.e. equipment inspections and freezer charts) as required by clinical SOP's and Federal Regulations.
•Maintain the E-cart and all regulatory documentation.
•Ensure completion and accuracy of Adverse Experience Reports.
•Maintain the accuracy of all raw data collected during study conduct.
•Ensure compliance with all applicable regulations (i.e. OSHA, FDA, State Health Department
Complete and submit required Regulatory Documents
•Negotiate Study Budgets
•Negotiate Contract Language
•Liaison between IRB, Sponsor and site
•Completion of Feasibility Questionnaires
•Ensure Study Advertisements receive IRB Approval