Clinical Trial Associate

About Vericel Corporation

Vericel Corporation is at the forefront of developing advanced cell therapies that enhance treatments in sports medicine and severe burn care. Our innovative regenerative medicine products such as MACI for knee cartilage repair, and Epicel and Nexobrid for burn treatment, demonstrate our commitment to cutting-edge science and improving patient outcomes.

Position Overview

The Clinical Trial Associate (CTA) plays a critical operational role by independently managing daily activities associated with clinical studies. This role ensures adherence to timelines, regulatory standards, and Good Clinical Practice/Good Documentation Practice (GCP/GDP) guidelines. It supports clinical trial planning, execution, and compliance monitoring within a fast-paced and highly regulated environment. The position is based in Burlington, MA with an in-office schedule Monday through Thursday and remote work flexibility on Fridays.

Key Responsibilities

• Lead and support site management efforts including regulatory startup activities, review of informed consent forms, overseeing site Institutional Review Board (IRB) submissions, communication management, and conducting investigator site file reviews both on-site and remotely.
• Organize and facilitate meetings by preparing agendas, guiding discussions, and documenting decisions and actions.
• Deliver training initiatives on GCP/GDP standards, study protocols, study-specific logs, and investigator site file expectations to ensure compliance.
• Manage coordination and tracking of Investigational Products (IP) documentation.
• Monitor and report on study metrics like regulatory package status, Trial Master File (TMF) completeness, and site progress; propose risk mitigation plans as needed.
• Prepare for inspections and audits by conducting internal reviews, supporting staff readiness, and participating in mock audits to maintain continuous inspection readiness.
• Maintain and organize the TMF by addressing gaps, ensuring document completeness and accuracy to meet inspection standards.
• Draft and contribute to key study documents including Informed Consent Forms, study plans, and templates.
• Assist Clinical Research Associates (CRAs) with monitoring visits through electronic site file assessments and cross-checking TMF and ISF documentation.
• Manage day-to-day interactions and deliverables for third-party vendors such as central laboratories and imaging providers ensuring schedule adherence.
• Review and file vendor documentation accurately in the TMF.
• Contribute to departmental process improvements such as SOP development, tool creation, and system optimization.
• Maintain clinical systems like Clinical Trial Management System (CTMS) and Smartsheet ensuring precise metric tracking.
• Oversee study training compliance by developing training matrices and maintaining curriculum materials.
• Manage Central IRB activities including submission oversight, approval tracking, and maintaining cross-functional IRB tracking tools.
• Perform contract and purchase order management, invoice tracking, and facilitate site payments.
• Handle protocol deviation management, data and medical review committee submissions, and ClinicalTrials.gov updates.
• Coordinate planning for Investigator Meetings and specialized surgeon training programs.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or a related discipline such as Biology, Nursing, or Pharmacy.
• At least two years of experience in clinical research or clinical operations, preferably within a pharmaceutical or biotech sponsor environment.
• Solid knowledge of clinical trial regulatory standards and documentation guidelines including ICH-GCP and FDA requirements.

Compensation and Benefits

The anticipated salary range for this role is $80,000 to $93,000 annually, subject to candidate qualifications and experience. Additional benefits may include bonuses, incentives, equity options, and other perks.

Work Schedule

The position is primarily in-office Monday to Thursday at the Burlington, MA location, with the option to work remotely on Fridays.

Equal Employment Opportunity

Vericel Corporation is an Equal Opportunity Employer committed to diversity and inclusion, ensuring fair treatment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, or disability status. As a federal contractor under VEVRAA, priority referrals for protected veterans are encouraged.