Clinical Trial Associate

Role Summary

This position as a Clinical Trial Associate involves supporting the daily operations of clinical trials, including documentation management and coordination activities necessary to effectively conduct investigational studies in oncology. The role operates under the guidance of Clinical Trial Managers, aiding vendor management, study startup, and trial maintenance.

Key Responsibilities

• Develop and maintain tracking systems and tools essential for clinical study processes from initiation through closeout.
• Assist in drafting and reviewing clinical documents such as study protocols, informed consent forms, and clinical plans.
• Schedule and organize meetings—prepare agendas, document decisions, and follow up on action items.
• Manage version control and prioritize clinical documents and related projects independently.
• Facilitate procurement and vendor engagement, overseeing RFP distribution, contracting, and purchase orders.
• Organize SharePoint sites and centralized study files to ensure organized documentation.
• Coordinate study-specific training and manage laboratory sample tracking along with vendor oversight.
• Support clinical supply logistics, including shipment tracking and review of regulatory submissions.
• Collaborate with Clinical Operations on assigned projects, maintaining effective communication to troubleshoot and resolve trial-related issues.

Required Qualifications and Experience

• Bachelor’s degree or equivalent education.
• At least one year of clinical operations experience in a Sponsor or CRO setting; three or more years strongly favored.
• Demonstrated knowledge of drug development lifecycle, regulatory affairs, and clinical ops documentation from study startup to closeout phases.
• Familiarity with Good Clinical Practice (GCP) guidelines, relevant federal regulations, and electronic Trial Master File (eTMF) management.
• Proficiency with Microsoft Office applications including Excel, Word, PowerPoint; knowledge of MS Project and SharePoint is an advantage.
• Excellent organizational, communication, and teamwork capabilities with the ability to manage multiple tasks and deadlines efficiently.
• Strong attention to detail and quality control in clinical trial documentation and operations.
• Ability to function in a dynamic, flexible working environment.

Additional Work Conditions

• This is a contract position initially lasting six months, with the possibility of extension.
• Hybrid work format requiring three days onsite presence in Cambridge, Massachusetts.

Equal Opportunity Employer Statement

The employer is committed to diversity and inclusion, encouraging applications from individuals with disabilities and protected veterans. Completion of a voluntary self-identification form is available and does not affect employment conditions.