Clinical Trial Associate

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee clinical trial laboratory services and engage with clinical investigator sites.

• Assist the primary Clinical Trial Manager (CTM) in various tasks.

• Utilize expertise in GCP, ICH, regulatory standards, and Title 21 of the Code of Federal Regulations.

• Ensure prompt resolution of queries directed to investigator sites and relevant parties.

• Analyze trends and provide insights on the performance of Investigators and PathAI BioPharma Laboratory.

• Monitor the activities of investigators, laboratory performance, study requirements, queries, outstanding results, and testing turnaround times.

• Work together with data management to rectify data discrepancies.

• Organize and manage the storage of specimens, including their receipt, retrieval, and shipping.

• Coordinate with external vendors and sponsors to ensure the delivery of laboratory kits and test outcomes.

• Conduct routine study tasks, such as maintaining site lists, laboratory manuals, laboratory kit orders, specimen management reports, case assignments on the PathAI AISight CT Platform, and outstanding lab analyses.

• Assist with administrative tasks for the CTM, including tracking action items, documenting meeting minutes, and mapping processes.

• Provide backup support for the CTM, including client interactions and study oversight.

• Collaborate with various functional areas, vendors, laboratories, Engineering, and support services.

• Manage site-level project information and escalate any discrepancies.

• Help prepare meeting and training materials.

• Support start-up deliverables, milestones, project documentation, and close-out procedures.

• Perform additional administrative or process-related tasks as required.

⛳️ Requirements

• Minimum of 3 years of clinical research experience in medical device and/or drug development clinical trials.

• Bachelor's degree in a relevant scientific field.

• Strong organizational abilities.

• Keen attention to detail.

• Capacity to handle multiple tasks simultaneously.

• Experience with digital pathology, radiology, or other imaging technology-based clinical trials is highly advantageous.

• Project Management Certification is a beneficial addition.

🏝️ Benefits

• Option for remote work.

• Relocation benefits are not offered for this position.