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Clinical Trial Specialist

Company: Ascent
Location: San Rafael
Posted on: June 21, 2019

Job Description:

Title: 19-04058 / Clinical Trial SpecialistLocation: San Rafael, CA (Local Residents will be prioritized)Industry: Biotechnology / PharmaType: Clinical ResearchLevel:?Associate-Level (BS/BA degree with 2 years of industry experience)?Bay Area residents, who submit a cover letter will be viewed first!?Seeking a clinical research professional passionate about operations with a minimum of 2 years? experience in Clinical Operations, focused on working to ensure delivery of quality data, and committed to helping our patients. ?Qualifications:

  • BA/BS or higher in nursing, life or health sciences is preferred.
  • Industry or relevant experience in lieu of education is considered.
  • 2+ years pharmaceutical industry experience.
  • Relevant Clinical Trial or clinical study experience needed?Essential responsibilities:
    • Study Specialist tasks:
    • related to site management and/or study management and oversight activities as delegated by SETL, Study Operations Lead (SOL), or Regional Operations Lead (ROL).
    • support study matters that impact study timelines, quality and budget.
    • Responsibilities may include, but are not limited to:
    • Assist with study coordination activities
    • Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates
    • Assist with inspection readiness activities
    • File, track and maintain TMF
    • Maintain internal/external contact list
    • Conduct electronic documentation and records management
    • Perform document tracking and signature/approval follow-up, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation
    • Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)
    • Ensure timely study entry and updates to ClinicalTrials.gov
    • Prepare investigator meeting materials
    • Design and prepare study related materials for the training of internal and external staff
    • Assist or lead in study conduct activities
    • Start-up Activities:
    • Facilitate CDA and contract execution.
    • Assist with regulatory package review
    • Request and distribute insurance certificates for sites ? as delegated by, and under the oversight of, Study Lead
    • Contact and identification of investigators for participation in clinical studies Provide administrative assistance with internal and external meetings including investigator meeting(s)
    • Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF)
    • Ensure accurate study entry and updates to ClinicalTrials.gov throughout life of study
    • Enrollment and Maintenance:
    • Issues identification, resolution, and escalation
    • Track site payments and vendor invoices
    • Track patient status
    • Review of study ICFs and other study documents
    • Assist with samples reconciliation and query resolution
    • Conduct MVR review and appropriate escalation of identified issues
    • Assist with MVR tracking and filing of sponsor comments
    • Identify issues, with potential resolution, and escalate when appropriate
    • Closure of study:
    • Conduct study closure activities (sites, reconciliation activities, filing & archiving)
    • Track, collate clinical trial documentation related to CSR appendices Cross-functional
    • Representation
    • Assist with cross-functional meeting coordination and minutes
    • Assist study supplies management
    • Lead TMF close-out activities, including document review, uploading and reconciliation ? The Clinical Trial Specialist is expected to be in the process of developing foundational competence in critical areas required for success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Strategic Thinking, Planning and Analysis, and Problem solving and Decision Making. For example:Responds promptly with clear, organized written and oral communicationSeeks out, and understands the value of, opportunities to interact with peers and stakeholders; builds a network of internal and external peersTakes ownership and accountability for completing assigned tasks and perseveres through obstaclesEmbraces new challenges or changed priorities and adjusts plans and priorities accordinglyThe Clinical Trial Specialist is also in the process of developing foundational technical competence in Study Management and Execution, Compliance and Quality, Drug Development and Study Design, and Product and Therapeutic Area Knowledge.??*Those authorized to work in the U.S. are encouraged to apply / Unable to Process H1B visa at this time / Unable to work on a C2C basis for this role*??

      Company Description:

      About Ascent:Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent---s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, Oakland , Clinical Trial Specialist, Other , San Rafael, California

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