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Research Associate, Clinical II

Company: Ascentiant International
Location: San Rafael
Posted on: March 23, 2019

Job Description:

Job Title Research Associate, Clinical II Location San Rafael, CA Duration 12 months Duties Primary point of contact on all biospecimen management activities across all assigned clinical trial studies Collaborate with relevant vendors, or Clinical Operations (CLO) vendor specialist, on any biospecimen related logistics, issues and queries Act as point of contact for all study team requests, lab queries and issues regarding biospecimen management throughout life of assigned studies participate in study team meeting and provide appropriate guidance for biospecimen-related activities Provide input to study team for development of feasibility assessments for relevant biospecimen processing, collection, storage, and shipping activities to ensure sites and labs can meet biospecimen-handling needs of the study Participate in study team meetings as a standing member during early planning phases, and continue to participate in study team meetings on an ad-hoc basis throughout the life of a study Review biospecimen handling sections of ICF template provide input and guidance to study team on any site specific modifications to ICF Update biospecimen consent tracker with relevant ICF information and document any issues impacting ability to collect, store, or use biospecimens in CBMS Labmatrix Provide biospecimen-related input into vendor contracts, SOWs, lab specifications, laboratory manuals, manifest, and other relevant documents early on in the contracting process, including an agreement that the labs will adhere to biospecimen handling specifications as entered into CBMS Labmatrix Ensure that each assigned CLO and MAF studyprogram is set-up in the CBMS Labmatrix prior to First Patient In (FPI). Participate in introductory call with chosen lab vendors, along with any other calls relevant to biospecimen management Skills Participate in study-specific protocol working group Input and maintain all biospecimen-relevant information into CBMS Labmatrix for each assigned clinical trial study, i.e., outlining biospecimen stakeholder contacts, number and quantity of each biospecimen collected as related to the study's schedule of events, any unique biospecimen handling or operational requirements, including the details of testing destinations and related shipping requirements Responsible for documenting and escalating any unresolved biospecimen-related discrepancies to CBM Manager Collaborate with Clinical Data Management (CDM) to align on CDM schedule of events regarding vendor transfer specification timing and development Provide input for vendor data transfer specifications and work with CBMS Labmatrix system owner to determine system compatibility for accurate data tracking Manage biospecimen tracking and reconciliation activities for all active studies in CBMS Labmatrix, and ensure that these activities are successfully updated before the status of study is transitioned to closed Act as the first point of contact for sample request fulfillments for assigned study exploratoryassay developmenthealth authority requests. Review shipping requirements Participate in the cross-functional meetings to consult on decisions regarding biospecimen collection, kit design, shipping schedule, and data deliverables Develop a Project Specific Scope (PSS) between the external biorepository and client, which will be included in the Project Operation Procedure (POP) Create any study specific biospecimen disposal requests and escalate as appropriate Participate in CBM functional improvement projects, as needed Conduct all on-study tracking of specimens ndash this includes gathering input from study team members and relevant vendors Consult on training documentation for all responsible parties (study monitorsCRO partners, investigative sites as appropriate) on the biospecimen management procedures and the proper completion of biospecimen transfer documents Education BABS in life sciences or related degree. Experience in lieu of education accepted. 2-5 years of relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories) 3 years of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations Required Skills Individuals in the CRA II role are expected to demonstrate foundational Communication, Leadership, and Problem Solving skills and advanced Teamwork skills, including actively contributing to team definition of goals, roles and tasks proactively expanding one's network and work relationships outside the department ability to create inclusive and collaborative team and meeting environments ability to recognize and articulate and prioritize key issue that arise based on understanding of objectives ability to analyze and evaluate problems and seek-out and recommend possible solutions leveraging data effectively to communication points of view and influence outcomes Desired Skills The CRA II should demonstrate a foundational knowledge of all relevant technical competencies, including Vendor Management and Lab Operations, Good Practices and Compliance, and Drug Development such as understanding of biospecimen management, i.e., biospecimen collection, processing, storage and shipping understanding informed consent and its impact on biospecimen management understanding of specialty or central lab handling of biospecimens and related timelines solid understanding of GxP principals and how they impact biospecimen operational activities

Keywords: Ascentiant International, Turlock , Research Associate, Clinical II, Healthcare , San Rafael, California

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