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    Clinical Trial Associate

    Kelly Science, Engineering, Technology & Telecom
    0-5 years
    Not Disclosed
    Santa Clara
    10 May 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title:

    Clinical Trial Associate

    Company:

    Kelly® Science & Clinical

    Type:

    Part-time/Possible Full-time, Contract/Possible Direct Hire

    Location:

    Santa Clara, CA

    Hours:

    Approximately 20 hours per week (stronger candidates may be considered for full-time/direct hire)

    • Flexible hours
    • Onsite

    Compensation:

    $35.00 per hour

    Employment Terms:

    No C2C

    Job Description:

    The Clinical Trial Associate will support the Clinical Affairs department in the conduct of clinical research studies (IDE/Post-Approval/Post-Market) sponsored by a medical device start-up. This role involves assembling and distributing clinical study materials, maintaining the Trial Master File, collecting, filing, and tracking regulatory documents, tracking IRB/EC approvals and renewal dates, and managing device accountability and shipments. The position requires strong communication skills, the ability to work independently, and the ability to manage clinical projects in a fast-paced environment.

    Responsibilities:

    • Update and maintain the study Trial Master File (TMF) and keep all study files current.
    • Manage device accountability activities, including shipping and receiving.
    • Prepare study materials for site initiation visits and ongoing study conduct.
    • Support document translations.
    • Provide support to sites and field monitoring personnel by shipping study supplies and updated binders/forms.
    • Assist with administrative activities related to Investigator and Coordinator Meeting logistics and materials.
    • Generate and maintain clinical affairs-related metrics.
    • Assist in the creation and/or submission of clinical study reports, regulatory submissions, publications, and presentations.

    Qualifications and Experience:

    • Experience supporting a department.
    • Familiarity with Medical Device product trials and regulations; working knowledge of GCP is a plus.
    • At least 1 year of experience with Trial Master File support.
    • Exceptional time management skills; ability to multi-task and prioritize.
    • Advanced oral and written communication skills.
    • Ability to work independently and with teammates.
    • Good problem-solving skills.
    • Excellent communication and interpersonal skills with the ability to maintain ongoing communications with department staff, clinical study site personnel, and other employees.
    • Personal attributes: independent, decisive, accurate, detail-oriented, multi-tasking, organized, and flexible.

    Additional Qualifications:

    • Associate’s Degree/College Diploma desired; Bachelor’s degree in health sciences or related field preferred.
    • Proficiency in Microsoft Office.

    Employer-Provided Information:

    • Pay range in Santa Clara, CA: Exact compensation may vary based on skills, experience, and location.
    • Base salary: $35/hr

    If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

     

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