Clinical Trials Associate - CEDENT

The Clinical Trial Associate supports clinical trial planning and management under the guidance of the Director of Clinical Operations or Clinical Trial Manager. As a key team member, this role provides administrative and operational support throughout the clinical study lifecycle, ensuring compliance with company policies, procedures, and regulatory standards.
 

• Provide administrative support, including scheduling and documenting meetings, maintaining tracking logs, and coordinating trial communications.

• Manage and maintain the Trial Master File (TMF), ensuring timely submission of essential documents and compliance with Standard Operating Procedures (SOPs).

• Track clinical trial progress, including enrollment, status updates, and necessary reports, across assigned studies.

• Assist in preparing and distributing trial documentation, including pharmacy manuals, regulatory binders, lab manuals, and training materials.

• Collaborate with external vendors to distribute trial materials to sites and team members, and manage shipments of study-related supplies.

• Collect, process, and track regulatory documents required by the FDA and other authorities, maintaining high-quality records and supporting study close-out.

• Identify and escalate issues as needed, while proactively supporting the study team in resolving trial-related challenges.

• BA/BS in a related field with 2+ years of experience in Clinical Operations, or equivalent experience without a degree.

• Oncology experience preferred.

• Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Strong written and verbal communication skills, with the ability to establish effective working relationships.

• Excellent multitasking, attention to detail, time management, and organizational skills.