HireFT
Browse JobsHow it worksPricingAboutSuccess Stories
    Back to jobs
    PS

    PSG Global Solutions

    Outsourced Recruiting Support

    Clinical Research Associate

    Tucson, United StatesOn-SiteContract2+ yrs experiencePosted 3w ago
    All PSG Global Solutions jobs

    Job description

    POSITION SUMMARY:

    Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays and biomarkers developed by Ventana Medical Systems. Works closely with study managers 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).

    ESSENTIAL FUNCTIONS:

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

    Site Management & Monitoring:

    • Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with Roche and Ventana 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.

    Study Implementation:

    • Assists in preparation 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 site and trial master files.
    • 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.

    Formal Training/Education:

    Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience.

    Experience:

    • 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.
    • 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.

    Knowledge, Skills and Abilities:

    • 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
    • Ability to complete intermittent overnight travel up to 30%.

    Arnette Fleras Manansala

    Consultant

    Real Staffing Group

    Direct line: 619.450.1016

    ph.linkedin.com/in/arnette-manansala-478b91114

    Job details are sourced from the employer's original posting.

    Open job posting
    PS

    About the company

    PSG Global Solutions

    PSG is the world’s largest and fastest growing provider of outsourced recruiting support. PSG has clients across the globe, including four of the world’s ten largest staffing companies, 20% of the Staffing Industry Analysts Top 50 and multiple Fortune 500 corporations. With decades of experience in both staffing and the broader outsourced services sector, our services are easy to implement, cost effective, and drive real bottom line results. We have close to 1,200 people at our recruiting centers in the Philippines, the preferred offshore location for supporting the US and global English speaking countries. We built our company from the ground up to take advantage of an offshore delivery model closely aligned with onshore client management. With this approach, our goal is to deliver onshore performance while significantly lowering costs with offshore frontline resources. Many of our customers have had poor experiences with offshore support prior to working with us. With these customers in particular, we are thrilled when they become a case study and talk about their success in our marketing materials and with their colleagues. We partner with every customer using a consultative approach to establish a value delivery framework to ensure we are improving their profitability with every PSG resource assigned to their team.

    View all PSG Global Solutions jobs
    Industry
    Outsourced Recruiting Support
    Open roles
    362

    Interested in this role?

    Apply with HireFT

    Free to start — no card required.

    Your fit

    How well do you match?

    Sign in to see how your résumé lines up with this role.