• Sr. Clinical Research Associate

    Job Locations US-NJ-Jersey City
    ID
    2018-1228
    # of Openings
    1
    Category
    Clinical Development
  • Overview

    The Senior Clinical Research Associate is responsible for coordinating, monitoring, and providing oversight of the execution of clinical trials. He/she is accountable for completing assigned clinical trial activities on schedule, and in accordance with protocols, ICH, FDA and any applicable federal and/or local laws and regulations and standard operating procedures. As a senior-level CRA, contributes to supporting formal meetings, CRA training, vendor oversight and other critical processes.

     

    Responsibilities

    • Supports trial designated clinical trial manager in conduct of study management team meetings,  CRO meetings, and other vendor related meetings pertaining to the program
    • Supports entry and review of trial vendor invoices
    • Conducts review and summarization of trial data and metrics relevant to mitigating risk to data integrity and GCP
    • Supports data listing review and data cleaning activities in support of data base lock
    • Acts as primary interface for certain trial supporting vendors to ensure proper vendor oversight
    • Supports investigator meeting and CRA training activities
    • Tracks study performance and provide peniodic / regular updates to the team, including, enrollment updates
    • Conducts site selection visits to determine whether a given site is qualified for participation in a clinical trial (including physical plant and staff capabilities) and provide written summary of findings
    • Conducts site initiation visits, interim monitoring visits and close-out visits and provide written summary of findings
    • Monitors clinical studies to ensure quality patient recruitment and conformance to GCP and study protocols
    • Creates site information forms (templates and completed forms)
    • Collects sponsor and investigator site-related sign-offs
    • Assists in the design of case record forms (CRFs)
    • Collects and reviews CRO monitoring reports and other study documents (i.e., CRF, IICF, Regulatory documents, etc.) and reports key findings
    • Collects and reviews all source documentation and identifies and resolves discrepancies in a timely manner
    • Ensures a'II relevant study-related materials and supplies are at the site prior to initiation of the site and ensures that adequate supplies are maintained at the site throughout their participation in the trial
    • Assists sites in the compilation and submission of site-specific Ethics Committee (i.e., IRB) documents
    • Collects and/or reviews completed CRFs and ensures transfer to the Data Management group for review and entry
    • Supports planning, manag·ing, and reconciling of Clinical Working Files (CWF) and/or Trial Master Files (TMF)
    • Performs other departmental duties as assigned

     

    Qualifications

    • Minimum BS/BA degree in life/health sciences or related field 
    • Minimum of 5 years clinical research/ development, including a minimum of 3 years’ experience in functional area support of clinical execution
    • Proficient in FDA regulations and GCP/ICH guidelines
    • Strong knowledge of the medical, scientific and clinical research aspects of pharmaceutical trials
    • Knowledge and experience in clinical trial design, analysis and reporting
    • Demonstrated ability to contribute successfully in a multi-disciplinary team environment/matrix organization coupled with the ability to guide others with less experience and help build departmental competencies
    • Strong communication, interpersonal and analytical skills
    • Competency in Windows, MS Office, MS Project, Lotus Notes, and other related computer software
    • Ability to travel 20% of the time (to domestic and internal sites)

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