Clinical Project Associate

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POST DATE 9/9/2016
END DATE 10/13/2016

Nektar Therapeutics San Francisco, CA

Company
Nektar Therapeutics
Job Classification
Full Time
Company Ref #
360755
AJE Ref #
576125543
Location
San Francisco, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Assists with all aspects of the design, planning, and implementation of clinical research projects. Participates in and coordinates the protocol and final clinical study report writing efforts. Assists with conduct of pre-study, initiation, and interim clinical study monitoring visits. Coordinates activities of clinical site to ensure compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. Periodically travels to field sites to supervise and coordinate clinical studies. May assist in drafting clinical study protocols.

Coordinates study-related activities with site and other internal departments. Provides support to the Clinical Trial Manager with study-related tasks to ensure efficient execution of clinical trials. Liaise with contract organizations, vendors and other suppliers of project support services to ensure study deliverables are met. Assists with pre-study, initiation, interim monitoring and close-out of a clinical study. Assists with site communication and problem solving. Assists site with submission of essential documents. Collaborates with Documentation Specialist to set up and maintain the Trial Master File (TMF). Ensures collection and review of site's essential documents. Effectively maintains the TMF, ensuring it is complete, accurate and up to date throughout the life cycle of the clinical study and assists with archival of the TMF when the study is complete. Assists with distribution and control of clinical, regulatory and study-related documents (e.g., protocols, informed consents). Maintains project documents, i.e., confidentiality agreements, clinical consultant agreements and service agreements. Maintains all aspects of documentation on department database/team rooms. Helps to ensure compliance with regulatory and Good Clinical Practices (GCP) requirements prior to shipment of clinical supplies. Assists in ordering and maintenance of clinical supplies for sites and the study team. Assists with the maintenance of a device/drug inventory system and tracks distribution of clinical supplies to site or third party packager. Coordinates and assists in review and approval of labels for clinical product(s). Assists with the design of Case Report Forms (CRFs). Assists with the creation of project specific tools, instructional manuals, protocols and informed consents. Assists with the coordination and meeting logistics for clinical advisory, consultant or expert meetings and study-related internal and external meetings. Provides input on agendas. May maintain meeting minutes, create materials and liaise with meeting planners. May involve 10-20 % travel as required to clinical sites to perform study monitoring, including drug accountability, regulatory document review and other related tasks. Works on project objectives to meet timelines and deliverables. Maintains the budget planning system to track specific and defined clinical projects goals and deliverables. May act as backup Clinical point person for the JD Edwards MRP system.