Clinical Trial Assistant, (US) Burlington, MA

CellCentric Limited; Burlington (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

CellCentric Limited is seeking a Clinical Trial Assistant in Burlington, MA, to provide vital support to the Clinical Operations team for late-stage clinical trials. You will be responsible for maintaining trial documentation, coordinating meetings, and supporting data management. Candidates should possess a degree in a life science or relevant experience in clinical research, along with strong interpersonal skills and accountability. Join us as we foster a supportive and inclusive culture in our team-oriented environment.

Qualifications

• Previous experience as a Clinical Trial Assistant on a CRO/Pharma or Biotech.
• Strong ability to build trust, integrity, and respect.
• Demonstrated accountability in delivering results.

Responsibilities

• Maintain Trial Master File (TMF) filing according to GCP and SOPs.
• Creation and management of investigator site files.
• Ensure timely communication with trial sites and adherence to timelines.

Skills

Interpersonal and communication skills

Analytical mindset

Ability to work independently and collaboratively

Trust and credibility

Education

Degree in a life science or health-related discipline

Relevant clinical research, healthcare, or administrative experience

Job description

Clinical Trial Assistant, (US) Burlington, MA

Position Summary

The Clinical Trial Assistant (CTA) provides essential administrative and operational support to the Clinical Operations team for late-stage clinical trials. This individual will contribute to the success of the team and organization by delivering role-specific responsibilities while upholding our core working behaviors of Trust and Respect, Communication and Feedback, Accountability and Reliability, Objectivity, and Team Balance and Enablement.

Key Responsibilities

• Maintain Trial Master File (TMF) filing in compliance with applicable GCP requirements and CellCentric SOPs.
• Creation and compilation of investigator site files.
• Ensure all documentation is filed and maintained according to GCP and company SOPs.
• Track and manage study approvals, protocol amendments, and essential documentation updates.
• Assist in setting up investigator meetings, site initiation visits, and study monitoring visits.
• Maintain communication with clinical trial sites, ensuring timely collection of documents and adherence to study timelines.
• Track site activation, recruitment progress, and key trial milestones.
• Support data entry, query resolution, and reconciliation of trial-related information.
• Prepare study reports, meeting minutes, and status updates for internal and external stakeholders.
• Support the tracking of clinical trial budgets and invoices related to investigator payments and vendor services.
• Assist in developing and maintaining SOPs relevant to clinical trial operations.
• Provide administrative support for clinical team meetings, including scheduling, agenda preparation, and minute-taking.
• Manage trial-related correspondence and maintain organized records.
• Support the Clinical Operations Team with appropriate project and sit management activities, as required.
• Travel with the CRAs on site to help and assist with the investigator site file and ad hoc site tasks.
• Adhering to Company Standard Operating Procedures, Policies and applicable regulatory requirements.
• Execute day-to-day responsibilities of the role, ensuring quality, accuracy, and timeliness.
• Collaborate effectively with colleagues, sharing knowledge and supporting team goals.
• Contribute to problem-solving and decision-making processes with an objective, data-driven approach.
• Communicate clearly and proactively with stakeholders to ensure alignment.
• Demonstrate ownership of tasks and follow through to successful completion.
• Support team members through constructive feedback, mentorship, and collaboration.

Skills and Qualifications

• A degree in a life science or health-related discipline is preferred. Candidates with relevant clinical research, healthcare, or administrative experience may be considered in lieu of a degree.
• Previous experience as a CTA on a CRO/Pharma or Biotech.
• Strong interpersonal and communication skills, with the ability to adapt to different audiences.
• Proven ability to build trust and credibility through integrity, openness, and respect.
• Demonstrated accountability in delivering results and meeting commitments.
• Analytical mindset with the ability to use facts and data to guide decisions.
• Ability to work both independently and collaboratively within a team.

Working Behaviors (Core Expectations)

• Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.
• Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback.
• Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
• Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.
• Team Balance and Enablement: Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.

Why Join Us?

At CellCentric we believe success is built on great teams. By embodying these working behaviors, every member contributes to a high-performing, supportive, and inclusive culture where individuals and the business thrive together.