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Clinical Research Associate I (SC4) in Tucson, AZ at Fast Switch - BHJOB13738_53056 GD

Company: Fast Switch
Location: Tucson
Posted on: June 16, 2019

Job Description:



Job Description

Job ID: 53056Clinical Research Associate I. We are seeking a Clinical Research Associate I--for a contract opportunity with our Tucson, AZ client. Candidates must have experience working in a clinical or doctor's office that actively participates in clinical research studies sponsored by pharmaceutical, device, or diagnostic companies. Or has experience working as a CRA/Monitor for a Pharma or other clinical research organization (CRO).

Responsibilities:


  • Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by the client, Medical Affairs.
  • Works closely with study manager and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring and closing study conduct in accordance with the principles of Good Clinical Practice (GCP).--
  • Works closely with project managers, Medical Managers, and Directors with project planning, implementation, and facilitating Medical Affairs various types of non-registrational projects.

    Essential Functions:

    The following related tasks are fundamental to this position, but they may be expanded or omitted at the discretion of the Study Manager to more effectively complete clinical research and project activities:

    Site Management & Monitoring:

    • Conducts in-house, and may independently perform on-site monitoring in accordance with--Standard Operating Procedures, ICH GCP guidelines and Regulations.
    • Participates in assessing study risks.
    • Communicates on behalf of the study manager with investigators and site staff.
    • Prepares study performance reports and provides input into study budgets.
    • Manage study supply inventory and shipping.
    • Conduct and assess site readiness and assist in creating site monitoring plans
    • Work across multiple project teams, indications, and differing study designs
    • Assist in the creation of study materials (CRFS, operation manuals, protocols, etc.).
    • Assist in the creation of departmental operating procedures and tracking systems.

      Study Implementation:

      • Assists in the creation, management and independent execution of:


        • Study training presentations for investigators and site staff.
        • Study supply ordering and shipping.
        • Investigational product release, labeling, accountability at study sites.
        • Site Readiness and Site Monitoring Plans.
        • Assay transfer and assay qualification activities.
        • Study records including paper and eTMF and electronic clinical trial management system
        • Site qualification, site initiation, routine monitoring and close out visits and reports.
        • Document compilation for clinical study reports and document archive activities.
        • Data management activities including user acceptance testing, data entry, and data verification as needed.

          Departmental Roles:

          • Works within project teams to facilitate the conduct of standard study designs.
          • Participates in clinical affairs meetings and completes independent activities to support departmental functions.
          • Completes all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking and training.
          • Adopts clinical practices that promote Quality First Time.

            Additional Qualifications:

            • Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.
            • Familiar with FDA 21 Code of Federal Regulations 812 and 814.
            • 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience required or equivalent combination of education and experience.--
            • 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.
            • Excellent time management skills.
            • Ability to give presentations and teach others.
            • Ability to work effectively in a team, and also work independently on assigned tasks

              Preferred:

              • At least 1-2 years prior research experience in pharma, device, or diagnostic research
              • Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred.
              • A background in biomedical/healthcare services with laboratory experience preferred.
              • Prefer local candidates only, but would consider someone outside AZ, if they can relocate in a short time frame
              • Proficient at managing multiple priorities and tasks
              • Experience working in a pathology lab is a plus
              • Willing to travel in the US and xUS. (30-60% travel; dependent on project need)

                To view all our open positions, please go to: https://fastswitch.jobs.net/en-US/

                scrow@fastswitch.com


Keywords: Fast Switch, Tucson , Clinical Research Associate I (SC4) in Tucson, AZ at Fast Switch - BHJOB13738_53056 GD, IT / Software / Systems , Tucson, Arizona

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