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Sr. CRA

Company: Ascent
Location: San Carlos
Posted on: November 11, 2019

Job Description:

Sr. Clinical Research AssociateSan Carlos, CAPermanent PositionThe Senior Clinical Research Associate is a critical position within the clinical team. In close collaboration with the Clinical Trial Manager and/or Study Director, the Sr. CRA will work to manage and provide daily operational oversight of Contract Research Organization (CRO), study vendors, and clinical trial sites. The Sr. CRA will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and company SOPs.Specific Responsibilities:

  • Independently manages the study start up activities for multi-center, US and/or global based studies.
  • Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites' and CRA's overall performance
  • Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
  • Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs.
  • Leads or participates in vendor management activities (e.g. Central Laboratory, Central Imaging, CRO)
  • Performs in-house routine data listings review
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
  • Supports CTM and cross-functional representatives as required in relationship management tasks (e.g. contracts, study logistics, patient enrollment, safety, data management, etc.) to accurately coordinate clinical study activities.
  • Mentors and coaches junior staff new to Clinical Research (e.g. Clinical Trial Assistants)
  • Assists with the development of protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study related documents
  • Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
  • Performs other duties and assignments as required for the overall success of the projects.
  • Duties may change based on the status of clinical programs and the ongoing needs of the organization.Education:
    • BS/BA, RN, or equivalent with at least 4 years of clinical trial monitoring / clinical trial management and vendor experience in accordance with CFR, GCP and ICH Guidelines
    • 4 to 8 years' industry experience
    • Must have strong knowledge of ICH/GCP guidelines
    • Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
    • Strong experience managing early to late phases clinical studies and working with CROs and other study vendors
    • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
    • Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language
    • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
    • Ability to "roll up your sleeves? and individually contribute results to a research and development effort
    • Ability to travel up to 25%

      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, San Francisco , Sr. CRA, Other , San Carlos, California

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