Senior Clinical Trial Associate

Location: Andover, MA
Job Code: 130
# of openings: 1




POSITION TITLE:   Senior Clinical Trial Associate    REPORTING TO :  VP, OD&O

DEPARTMENT:      OD&O                               DIRECT REPORTS:  None





Assists project managers in clinical study conduct for 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 guidelines 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.




  • Work to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and government regulations.


  • Participate in study start-up and closeout activities


  • Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc)


  • Prepare essential documents package to support drug release


  • Create regulatory packages for IRB submission


  • Assemble and distribute regulatory binders to clinical sites and provide monitors with regulatory binder tracker in support of monitoring visits


  • Support project management activities including providing meeting minutes/agendas and weekly newsletter to the clinical team, preparing staff training summaries, maintaining the study Master Tracker, generating the list of applicable SOPs


  • Assist project managers in preparing study reports and collecting site status updates and study metrics


  • Maintain department server file


  • Set-up and maintain the Trial Master File for clinical projects


  • QC Trial Master File (for clinical projects where individual is not setting up and maintaining the file)


  • Participate in Study Operations planning and Risk Assessment discussions


  • Participate in Protocol and ICF development and QC process


  • Provide support to Clinical Operations for implementing process improvement actions, performing bi-annual reviews of applicable SOPs, and conducting departmental training sessions


  • Assist with Sponsor/IRB audit preparations and participate in response to audit findings


  • Acts as back up to Project Manager. 




  • Research Fundamentals


  • Study Coordination I


  • Knowledge of GCP/ICH regulations


  • Experience maintaining trial master files




  • Bachelor’s Degree in Nursing or Life Sciences, a minimum of 4+ years experience in clinical trials, or equivalent training and work experience. Recent grads will be considered.


  • Excellent communication and organizational skills 

Are you a returning applicant?

Previous Applicants:

If you do not remember your password click here.

Back to Search Results

New Search

Powered By Taleo