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Clinical Trial Associate (Onsite)

Company: TFS HealthScience - Contract Research Organization
Location: Sunnyvale
Posted on: June 19, 2022

Job Description:

Description

TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions team and looking for an experienced, highly motivated Clinical Trial Associate (CTA) who shares our vision of providing clinical research excellence. Our Strategic Resourcing Solutions team is a highly experienced international group of professionals led by an industry expert.

We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.

Our core values of Trust, Quality, Flexibility and Passion are what makes TFS the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. Together we make a difference.

TFS HealthScience is looking for a Clinical Trial Associate (CTA) to work onsite in Sunnyvale, CA or hybrid in the Bay Area. We look forward to receiving your application.

Responsible for the execution and support of clinical trials and regulatory submissions that are consistent with the overall business goals worldwide. Duties will be carried out under the supervision of a Clinical Trial Manager or higher level.

Key Responsibilities:

  • Prepare and review various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, and retrieval)
  • Manage Trial Master File (TMF), site payments and regulatory documents.
  • Perform ongoing reviews of TMF to assure quality of the documentation files and compliance with SOP, GCP and ICH Guidelines.
  • Support setting up of trial sites for executing the study, which includes ensuring each center has the trial materials, and assisting with training the site staff to trial-specific industry standards.
  • Support Clinical team with investigative site contracts and budget negotiations as required.
  • Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned field CRA(s).
  • Prepare clinical study binder materials (subject, regulatory, reference, and device accountability binders) and ensure timely shipment to clinical sites. - Maintain study documentation and correspondence.
  • Assist the project team in preparation for audits/inspections. May collaborate with field CRA and/or Lead CRA to address Corrective Action Plans (CAPA) and ensure quality and completeness of clinical trial documentation.

    Requirements
    • Bachelor's Degree, preferably in life science or alternatively, an equivalent combination of education, training and experience may be accepted in lieu of degree.
    • 2 years of previous experience related with site management and clinical trials within a medical device, pharmaceutical, biotechnology, CRO and/or healthcare setting required.
    • Experience with cardiovascular trials preferred.
    • Experience with eTMF systems preferred.
    • Experience with legal administrative tasks preferred.
    • Demonstrated proficient written and oral communication skills in English.
    • Proficient in software applications such as Word, Excel and PowerPoint and meticulous attention to detail required.

      Benefits

      A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS HealthScience is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. US benefits include:
      • Competitive salary & benefits package
      • Excellent career progression opportunities
      • Great corporate culture and work life balance

Keywords: TFS HealthScience - Contract Research Organization, Sunnyvale , Clinical Trial Associate (Onsite), Healthcare , Sunnyvale, California

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