Senior Clinical Trial Assistant
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POST DATE 9/8/2016
END DATE 11/9/2016
San Diego, CA
JOB DESCRIPTIONAPPLY Tocagen is a clinical-stage, cancer-selective gene therapy company focused on developing first-in-class, broadly applicable product candidates designed to activate a patient s immune system against their own cancer from within.
Every member of our team plays a significant role in our success. Tocagen hires individuals who share our passion for ending cancer mortality and have exceptional talent that will contribute to this goal.
Provides support to clinical operations during the conduct of clinical trials in the areas of document management, study conduct, and tracking of essential activities.
Duties and Responsibilities Include But Are Not Limited To:
Organize and maintain tracking systems and tools to support the conduct of a clinical trials from start-up to close-out
Create and Maintain accurate study trackers (e.g. contact lists, CRA travel Schedule, CRA site assignments, enrollment, site start-up activities)
Assist in creating & maintain the clinical operations budgets for all studies
Manage clinical operations invoicing process, including tracking and reviewing invoices to ensure alignment with work orders and study milestones, and follow up on queries
Coordinate study drug release activities
Provide overall back-up support for Clinical Supplies, managing practice kit shipments, ordering study drug kit supplies & components, and tracking of all clinical supplies for multiple studies.
Initiate, maintain, and reconcile study/site Master Files according to company SOPs and DIA TMF reference model
Prepares investigational site reference materials (i.e. screening/enrollment logs, delegation of site responsibilities forms, site monitoring log, etc.)
Attends project team meetings and produces minutes from the meetings
Provide clerical and administrative support for project teams (assemble study binders, shipment of study materials, maintain shared calendar, proofread and edit correspondence)
Prepare and distribute Regulatory binders, study reference manuals and other study supplies to sites
Schedule and set up study team and vendor meetings
Assist with/Distribute safety reports to all sites
Conducting site feasibility and tracking the outcome of the feasibility
Maintain study files in audit ready condition
Liaise with other Departments regarding issues relating to essential documentation and archiving
Serve as resource and subject matter expert in the use of the electronic trial master file system.
Assists with departmental administrative support as needed (such as organizing meeting rooms, calendar invitations, etc.)
Performs other duties as required.
Reports To: Executive Director, Head of Clinical Operations
Position Type: Hourly, negotiable according to experience and fit; package includes company stock options, as well as tax advantaged employee benefit plans