Blueprint Medicines

Senior Clinical Study Associate III

Blueprint Medicines Greater Boston
Blueprint Medicines

Senior Clinical Study Associate III

Blueprint Medicines Greater Boston
2 weeks ago 78 applicants

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Blueprint Medicines provided pay range

This range is provided by Blueprint Medicines. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$85.00/hr - $85.00/hr
Job Description

  • Participates in the day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, and data flow metrics from the clinical sites, CROs and central labs
  • Supports complex clinical trial activities in support of the Clinical Study Manager and other team members
  • Prepare study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
  • Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management
  • Ensures tracking of patient status throughout the study at investigative sites
  • Tracks and monitors sample collection, central laboratory reporting, and manages laboratory testing schedule
  • Assists with laboratory vendor management and liaises with the CRO and clinical trial sites to ensure appropriate sample handling, shipment and result reporting
  • Review monitoring trip reports, track data query reports, site visit metrics, and overall site performance
  • Attends site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with CRO
  • Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
  • Assists in the preparation of, and may present at investigator vendor meetings and workshops
  • Actively involved in the performance of study feasibility assessments
  • Review of site contracts and budgets for study start-up
  • Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation

Required Skills

  • 3 or more years of industry experience, working in Clinical Operations preferred
  • Experience working in a global clinical trial
  • Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
  • Understanding of study phases and general knowledge of how they apply to clinical development
  • Advanced knowledge of Word, Excel, and PowerPoint.
  • Knowledge of the principles and practices of computer applications in database management
  • Strong verbal and written communication skills.

Education

  • Bachelors’ degree or higher

  • Seniority level

    Not Applicable

  • Employment type

    Contract

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    Biotechnology Research

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