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.
- 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.
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.