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CR25 - Clinical Research Associate II (CRA II)

Company: Kelly Services
Location: Jacksonville
Posted on: September 20, 2019

Job Description:

In-House CRA II

Jacksonville, FL

RESPONSIBILITIES



  • Responsible for clinical study activities for multiple clinical sites for several to many ongoing clinical studies.

  • Conduct clinical monitoring site visits (primarily local) and monitor clinical trials in compliance with Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines, appropriate communications between site and sponsor, and deliverables as assigned by sponsor.

  • May assist in coordinating protocol, informed consent, and case report form development and compilation.

  • May assist with study material distribution.

  • Conduct clinical monitoring of study sites, ensuring test article accountability, human subject protection, and protocol adherence at investigational sites.

  • Review, retrieve, and report the trial data as the requirements dictate or as appropriate.

  • Ensure all work-related activities and decisions embody the clients core values.

  • Verify safety and wellbeing of study subjects are maintained for assigned study sites.

  • Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.

  • Execute clinical trials activities following established standard operating procedures, good clinical practices, and regulatory requirements.

  • Assume accountability for study site performance, providing high quality data according to overall project timeline.

  • Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues.

  • Respond to problems and assists in implementing corrective and preventive actions.

  • Verify Investigator Site Files at assigned Study Sites are maintained according to regulations and/or requirements/procedures.

  • Support patient recruitment and retention activities. Performs Site visits and ensures study site is compliant with Study Protocol and all Federal, State, local and company regulations, policies and procedures.

  • Assist with internal communication of important clinical data and events.

  • Support, when required, organization of investigator and other study training meetings.

  • Function as a reliable, trusted resource of accurate, up-to-date study site status knowledge as requested by key stakeholders.

  • May be involved in other tasks to support Clinical Operations and Operating Company as needed.

  • Support the implementation of new clinical systems/processes.

  • Interface and collaborate with investigators, IRB's/EC's, contractors/Vendors and company personnel as needed.

    QUALIFICATIONS



    • Bachelor of Science Degree, preferably in Life Science, Physical Science, Nursing or Biological Science.

    • 3-5 years of working experience as a clinical research associate with working knowledge of regulations and standards applied in clinical area and medical devices.

    • Medical device experience required.

    • Therapeutic area experience (ophthalmologic, not optometric) strongly desired.

    • Strong knowledge, understanding and application of principles, concepts and practices of clinical investigations/studies.

    • Strong organizational, analytical, oral and written communication skills.

    • Ability to collect and analyze data and ability to flexibly adjust to a dynamic working environment.

    • Equipment: Must be able to operate personal computer, printer, telephone, facsimile, copier, calculator; and be familiar with Microsoft office products, software as required.


      Why Kelly--?The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG--) is one focus within the full array of Kelly Services-- workforce solutions.

      Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

      The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.About

      Kelly Services--As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

      Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Keywords: Kelly Services, Jacksonville , CR25 - Clinical Research Associate II (CRA II), Healthcare , Jacksonville, Florida

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