What are the responsibilities and job description for the Clinical Trial Associate position at ClinLab Solutions Group?
ABOUT OUR CLIENT
Our client is a precision genetic medicines company advancing a growing clinical pipeline across hematology, oncology, and immunology. The organization is entering an exciting, high-impact phase as its programs move toward BLA submission, and the Clinical Operations team is expanding to support that growth. The company is known for a collaborative, science-driven culture.
ROLE OVERVIEW
Our client is seeking a Clinical Trial Associate to join their Clinical Operations team on a contract basis, with strong potential for extension or conversion to a permanent role. This person will support day-to-day trial operations, TMF maintenance, and inspection readiness activities for late-phase programs, working closely with the Clinical Trial Manager and Associate Director of Clinical Operations. This is a hybrid role requiring 2 days per week onsite in Cambridge, MA, and candidates must currently reside in the Boston area.
This position is a 6 month contract with strong potential to extend and convert to permanent.
PRIMARY RESPONSIBILITIES
• Assist the Clinical Trial Manager with day-to-day operational activities for assigned trials, ensuring objectives and timelines are met with high quality and in compliance with applicable SOPs and regulatory guidelines.
• Maintain clinical trial files including eTMF, project processes, tracking systems, and other study or departmental systems, with a strong focus on inspection readiness and QC.
• Support onsite activities and serve as a collaborative team member across Clinical Trial Manager and Associate Director functions.
• Liaise with Clinical Sample Management for tracking and coordination of biomarker testing with third-party and central labs.
• Collaborate with CROs and vendors to ensure timely training and system access for external stakeholders.
• Coordinate project team and departmental meetings, including associated documentation.
• Assist with vendor and clinical site agreements, budgets, purchase order tracking, and invoice reconciliation.
• Develop and maintain strong relationships with key stakeholders across the organization, CROs, vendors, and clinical sites.
QUALIFICATIONS
• BS in a science-based discipline preferred, with at least 2-4 years of experience in a clinical research environment; sponsor-side or academia experience welcome.
• Later-phase trial experience required; BLA submission experience or exposure a strong plus.
• Strong TMF/eTMF experience with an inspection readiness and QC focus.
• Basic understanding of drug development, including ICH-GCP guidelines.
• Self-motivated and comfortable with shifting priorities in a small company/biotech environment.
• Strong organizational skills, attention to detail, and ability to manage multiple parallel tasks.
• Excellent verbal and written communication skills.
• Must currently reside in the Boston area and be able to commute onsite 2 days per week.
Salary : $40 - $45