Senior Clinical Trial Associate

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

Description

JOB POSTING

 

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

DEPARTMENT:      OD&O                               DIRECT REPORTS:  None

 

 

 

SUMMARY OF POSITION:

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.

 

PRIMARY RESPONSIBILITIES:

 

  • 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. 

 

REQUIRED SKILLS AND ATTRIBUTES:

 

  • Research Fundamentals

 

  • Study Coordination I

 

  • Knowledge of GCP/ICH regulations

 

  • Experience maintaining trial master files

 

OTHER REQUIREMENTS:

 

  • 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 




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