Senior Clinical Trial Associate

Senior Clinical Trial Associate

16 Dec 2024
Massachusetts, Cambridge, 02138 Cambridge USA

Senior Clinical Trial Associate

Vacancy expired!

Senior Clinical Trial Associate



Responsibilities


  • Manage study-related vendors and serving as a point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metrics

  • Review monitoring reports, protocol deviations and data listings for studies

  • Coordinate cross-functional project-related activities (e.g., Clinical Data Review meetings)
  • Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planning

  • Lead the development of reports for communicating study progress and key metrics to Senior Management and program team

  • Perform initial review of invoices against contracted services

  • Assist with budget management
  • Prepare study timelines

  • Develop and manage study trackers and provide metrics as needed

  • Perform and/or overseeing site monitoring visits for clinical trials as needed

  • Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections

  • Prepare and maintain assigned program files

  • Ensure documentation is completed in accordance with Google Cloud Platform regulatory requirements and is consistent with the study protocols

  • Organize and prepare study files related to study tracking and reporting and submit to the Trial Master File within established guidelines


Qualifications


  • Requires a Bachelor's degree with at least 2+ years of relevant work experience in a pharmaceutical, academic or CRO environment

  • Working knowledge of ICH/Google Cloud Platform regulations

  • Working knowledge of clinical protocols

  • Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed

  • Ability to work independently with minimal direction/oversight and within a team structure

  • Ability to independently problem-solve or propose innovative solutions

  • Superior listening and communication skills

  • Experienced with leading small group meetings and/or managing vendor relationships

  • Positive approach

  • Proficient in the use of Microsoft Office, advanced skills in Excel highly desirable

If you are interested in this position, please email your resume to a.mcgrath (at) realstaffing.com

Referrals are welcomed!




EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.


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Job Details

  • ID
    JC24454413
  • State
  • City
  • Job type
    Permanent
  • Salary
    US$35 - US$48 per hour + negotiable
  • Hiring Company
    Real Staffing
  • Date
    2021-12-15
  • Deadline
    2022-02-13
  • Category

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