Temporary Clinical Trial Assistant
Sangamo BioSciences, Inc.
Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT
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Position: Temporary Clinical Trial Assistant Location: Brisbane or Richmond, CA Job Id: T # of Openings: 1 Manager: Sr. Manager, Clinical Oversight and Optimization Department: Clinical Operations Location: Brisbane, CA or Richmond, CA Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise. We are seeking top talent to join our mission. Let’s build a better future together. JOB SUMMARY: Sangamo Therapeutics is seeking an experienced temporary Clinical Trial Assistant to support study teams in the management and conduct of complex clinical studies. ESSENTIAL FUNCTIONS: – Assist with maintenance of study Trial Master Files through filing documents in Sangamo shared drive/eTMF (if used) and/or paper files when appropriate, performing routine QC of TMFs held by Sangamo or CROs, reporting on issues identified during QC and working with study teams to resolve any TMF issues identified. – Perform diversified administrative duties for the Clinical Department, serving as the primary administrative support for Clinical Operations and Clinical Science. Interface with internal/external contacts, relaying information, obtaining approvals, and scheduling meetings. – Activities include coordination of teleconferences, meetings (including both routine study meetings and Investigator Meetings), and materials as well as taking meeting minutes, routing minutes for review/approval, and filing approved minutes in the TMF. – Assist in distributing and tracking clinical documents, Case Report Forms, contracts, contract payments, and other materials to Investigator sites, CROs, and other external parties, as required. – Maintain records on contract and contract payments, and other materials, as required. – Make study updates to as requested by the study team and per Sangamo procedures. – Assist in preparing study conduct materials. This may include contributing to the development and review of study plans, manuals, consent forms, tools, and trackers, as requested. – Maintain study trackers and report study metrics under the supervision of Development Staff. – If requested, make necessary travel arrangements for department personnel, including scheduling & reservations, notifying organizations and/or officials to be visited. – Perform other work-related duties as required. EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: – Minimum of 2 years in administrative work supporting clinical studies at either a CRO or Sponsor. – Knowledge of ICH GCP guidelines and clinical study regulations. – Understands the concept of clinical study design and clinical study processes. – Proficiency in MS Word, Excel, and PowerPoint with graphics required. – Experience with Veeva eTMF preferred. – Experience with or ability to learn other computer systems, including databases, CTMS, EDC systems, and Microsoft Project. – Excellent organization, time management, oral and written communication, and interpersonal skills. – Able to perform multiple tasks simultaneously and appropriately prioritize deliverables. – Good quantitative skills, high attention to detail, and ability to do accurate, efficient data entry. – Self-motivated with the ability to function independently and as part of a team. – Candidate will be office-based (post-COVID) in the Richmond, CA or Brisbane, CA area. – Potential for occasional domestic and international travel (for meetings). Sangamo is an equal opportunity employer The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time. #LI-JM1