Clinical Trial Associate - Medical Devices

Location: Andover, MA
Job Code: 180
# of openings: 1

Description

POSITION TITLE:   Clinical Trial Associate                                REPORTING TO:  Associate Director, Clinical Operations

DEPARTMENT:      Medical Devices                                           DIRECT REPORTS:  None

SUMMARY OF POSITION:

Assists project managers in clinical study conduct for ophthalmic clinical projects across all investigator sites and ensures compliance with protocol and overall clinical objectives. As a member of the clinical team, relies on instructions and pre-established SOP’s to perform the functions of the job while working under immediate supervision of a supervisor or manager.   Performs day-to-day activities under the guidance of the project managers.

 

PRIMARY RESPONSIBILITIES:

  • Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and government regulations.
  • Participates in study start-up, conduct, and closeout activities.
  • Collects and reviews site regulatory documents for accuracy and completion (investigator statements, Financial Disclosure documents, CLIA waivers, etc).
  • Assembles and distributes regulatory binders to clinical sites.
  • Drafts and/or assists with the preparation of trial-related documents, tools and templates (start-up forms, ICFs, screening scripts, source documents, study logs).
  • Supports project management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites, and maintaining study status trackers.
  • Assembles and/or reviews regulatory packages for trial-related submissions to IRB/IECs, in accordance with ICH GCP, applicable regulations and Company SOPs.
  • Maintains the Trial Master File for all clinical projects.

 

REQUIRED SKILLS AND ATTRIBUTES:

  • Ability to work in a virtual, cross functional team environment.
  • Sound analytical and problem solving skills; ability to act with a consistent sense of urgency and acute attention to detail.
  • Knowledge of GCP/ICH regulations.
  • Experience maintaining trial master files.
  • Excellent verbal and written communication skills.
  • Ability to display commitment to consistently producing high quality work.
  • Exceptional organizational and time management skills in order to manage multiple trials.

OTHER REQUIREMENTS:

Bachelor’s Degree in Nursing or Life Sciences, one or more years’ experience in clinical trials, or equivalent training and work experience. Ophthalmic trials experience preferred. Recent grads will be considered.





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