Clinical Research Associate
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POST DATE 9/16/2016
END DATE 10/15/2016
Redwood City, CA
JOB DESCRIPTIONThe Clinical Research Associate is responsible for supporting clinical study management and monitoring activities according to PaxVax Standard Operating Procedures, ICH and Guidelines
Responsible for all aspects of study monitoring including study start-up activities; conduct of pre-study and initiation visits; routine monitoring and close-out of clinical sites; maintenance of study files; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plans
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
Monitor data for missing or implausible data; implement risk-based monitoring, as applicable
Conduct in-house review of Case Report Forms when applicable
Collect, review, track, and archive Site Essential Documents. Perform ongoing document review and collection throughout study start-up, maintenance and close-out periods. Collaborate with Regulatory, Quality and other departments as necessary to maintain the study TMF.
Assist in site selection and study feasibility tasks
Assist in preparation and checking for completion (and cross-checking to TMF) of site activation checklists and packages.
Participate in the preparation and ongoing review of study documents (i.e.: protocols, consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy Manual, User's Guides, Data Management Handbooks, and SOPs, etc).
Assist in coordination of SOP reviews, departmental training and recordkeeping
Ensure tracking of patient status throughout the study at investigative sites through collaboration with data management
Assist in tracking clinical samples from clinical sites to central labs and vendors
Provide clinical team support to Lead and field CRAs
Assist with timely shipment of clinical supplies (lab kits, binders, etc.) and study drug to sites in collaboration with vendors and regional CRAs
Coordinate meetings between PaxVax and Vendors, Contract CRAs, Investigative Sites, as needed
Maintain adequate site tracking records; input and maintain study information in tracking systems