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Clinical Research Associate II

Company: Ascent
Location: Pleasanton
Posted on: November 11, 2019

Job Description:

19-10460 / CRA II Location: Pleasanton, CA?Type: initial 6-month contract (w2) with the plan to extend every 6-months (up to 3years)Industry: Pharma/Biotech/BiopharmaTravel Requirement: Approximately 30% of time travel domestic.**MUST HAVE SITE MONITORING experience!! Ideally 2 years of site monitoring experience**Serious applicants please email your cover letter directly to bgalley@ascentsg.com after applying!!Summary of job:Participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and external parties to ensure compliance with the overall scientific study objectives. May work with investigators and key customers as well.?Must Haves:

  • 1-2 years of site monitoring experience within a related industry (Medical Field)
  • 2-8 years within clinical trial research
  • BS/MS/PhD degree
  • Must be able to travel frequently based on business need (30% on average)?Preferred:
    • Familiar with diagnostics, ?Medical Devices (IVD protocols), instrumentation products.?Duties specific to the first project:
      • Training emergency room staff
      • reviewing data from test (1-time test in emergency room)
      • Reviewing and creating Protocols
      • Point person for all questions regarding trial from (2) sites?General Duties: * Travels to field sites to monitor studies.* Receives instructions; plans and prepares studies.* Reviews study protocols, reports and manuscripts.Contribute technical and clinical operations expertise for these documents* Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.Collects and maintains legal and regulatory documentation, as applicable* Assumes responsibility for training and coordinating certification of study site personnel (emergency room training).* Ensures accurate and complete study management/data collection and transfer to data management* Ensures site compliance with regulations and study protocol.* Monitors the sites and provides technical assistance, as necessary.* Assists, prepares and manages study timelines* Manages material logistics for the studies.* Conducts reference material testing in-house.* Organizes investigator meetings, as necessary.* Participates in Project Team Meetings.* Keeps informed of trends and developments in clinical research.* Knows and effectively uses the broad concepts of a particular field or specialization to resolve problems of limited scope and complexity.* Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions.Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).* Excellent writing and verbal communication skills.* Well organized and detail oriented.* Impeccable record keeping and filing skills.?*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, San Francisco , Clinical Research Associate II, Healthcare , Pleasanton, California

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