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    Clinical Research Associate - Sunnyvale, United States - TEKsystems

    TEKsystems background
    Contract
    Description

    Description:

    Position Summary:

    The Clinical Operations team is seeking a Field Clinical Research Associate to maintain high standards with human study data collection efforts. The associate would assist the in-house Studies team and the CRO/Clinical Sites to facilitate the successful and timely conduct of Clinical Studies. The team is looking for someone who is flexible and can respond quickly, energetically, and enthusiastically to changes.

    Tasks:

    · Develop training materials and study tools for sites and CROs use, including generalizable templates

    · Conduct training for CRO and site in collaboration with SPS

    · Oversee Clinical Monitoring activities in accordance with the Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations, including identifying and following up on corrective actions

    · Track, collect, perform quality control, and maintain legal and regulatory documentation, as applicable for study eTMF

    · May be asked to assess sites, investigators and CROs for participation in clinical investigations

    · Work in accordance with internal quality system procedures and ensures study and site compliance with protocol and regulatory policies, procedures and/or guidelines during clinical studies

    · Develop and finalize study-specific subject facing materials

    Profile Description:

    The Field CSA role is more hands on with needing to handle and manage devices, develop training and other documentation, and manage (technical troubleshooting) issues and hold sites accountable to timelines, processes and quality. It'd be ideal if we could find someone with some technical experience - engineering background or having to deal with complex devices and/or software design as this usually gives more of a comfort level with the work. But that's not a hard requirement.

    Skills:

    GCP policies, CRA, ICH Guidelines, Field Clinical Research Manager, Field Clinical Specialist, Health technologies, Medical Device, contract research organization, site training, Clinical Trial Execution, Clinical Operations

    Top Skills Details:

    GCP policies, CRA, ICH Guidelines

    Additional Skills & Qualifications:

    Qualifications:

    · A minimum of 3 years of monitoring experience

    · Previous experience leading projects and Clinical study deliverables required.

    · Vendor and site management experience required

    · Fundamental knowledge and good understanding of GCPs, clinical study development process and logistics required

    Experience Level:

    Mid Level

    About TEKsystems:



    We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.

    The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.



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