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:
- 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