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Clinical Research Associate

Company: Advanced Clinical
Location: New York
Posted on: June 13, 2018

Job Description:


We are currently searching for a skilled professional to join a well-known clients team as Clinical Research Associate in New York, New York. The Clinical Research Associate role will contribute to the management and oversight of clinical trials while working closely with all R&D, Project Management, Regulatory Affairs and Pharmacovigilance team members. Their work will have a direct impact on not just the organization but also on the larger clinical industry, making this an amazing career opportunity.


  • Participate in the design of clinical trials and site-feasibility
  • Review trial documents including study protocols and amendments, patient information, informed consent forms, study manuals, monitoring plan, progress reports, and clinical trials reports
  • Create a comprehensive checklist of study requirements
  • Conduct pre-study visits and draft pre-study evaluation reports
  • Administer training to site personnel and evaluate the trial site and applicable personnel on an ongoing basis
  • Communicate with investigators and their staff, to ensure compliance with protocols, regulatory requirements, and good clinical practices
  • Perform on-site data verification, data integrity, and monitor CRF completion and queries using metrics standards
  • Write initiation visit and follow-up visit reports
  • Build appropriate intervention plan for the avoidance of redundant errors and/or deviations
  • Manage the integrity of investigator files, ensure accessibility of clinical and non-clinical materials, maintain the required documentation in the Trial Master File (according to company standards and applicable guidelines), and check for consistency with the contents of sponsor files
  • Verify compliance with procedures to apply if serious adverse events occur
  • Collaborate with investigators the obligations needed at the end of the study and write closure visit reports
  • Monitor clinical trial related budgets and resources allocation in collaboration with the clinical study managers
  • Anticipate, recognize and resolve issues proactively with the project team
  • Act as liaison between site personnel and the in-house clinical project team


    • Minimum 4 years of CRA experience in a pharmaceutical company or a CRO with on-site monitoring activities required
    • Oncology or nuclear medicine experience preferred
    • Strong understanding and experience in diagnostics, nuclear radioactive compounds required
    • Imaging experience required
    • Comprehensive knowledge in clinical trial conduct in accordance with ICH/GCP and other clinical trial-related regulations/guidelines
    • Experience in coordinating collaboration amongst investigative centers, clinical staff, and CROs
    • Knowledge in EC & CAs submission preparation
    • Working knowledge in EDC and CTMS systems
    • Experience in contract negotiation is preferred


      • Minimum of Bachelors Degree in Life Sciences required

        To be a best-fit your strengths must include

        • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
        • Organized. Youre an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
        • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
        • Problem-Solvers. As an action-oriented self-starter, youre eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
        • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
        • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

          About Advanced Clinical

          Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribunes Top Workplaces, Chicagos Best and Brightest Companies, and Best of Staffing Talent & Client, visit

          Regarding your application

          Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

          Keywords: Advanced Clinical, New York, Clinical Research Associate, Healthcare, New York, New York

          Click here to apply!

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