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.
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:
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.