Position Summary

The CTA position is an operational role responsible for the independent management of daily activities across clinical studies. This position ensures that all assigned trial activities align with established timelines, regulatory requirements, and GCP/GDP standards.

This role supports the planning, coordination and execution of clinical trials to ensure compliance with protocols, regulatory requirements and Good Clinical Practices. The position requires a strong attention to detail, proactive problem-solver who can track clinical trial activities and maintain a state of continuous inspection readiness in a fast-paced, highly regulated environment.

Schedule: This position is in-office from Monday - Thursday in our new Burlington, MA location, with flexibility to work remotely on Fridays.

Key Responsibilities

• Actively engages in site management activities, including assisting with site regulatory startup (including ICF review), providing oversight for site-level IRB submissions, managing site communications, and conducting onsite or remote investigator site file (ISF) reviews.
• Leads meeting coordination activities, including preparing agendas, facilitating discussions, and documenting key decisions and action items.
• Provides support for site training by presenting GCP/GDP requirements, study-specific logs, and ISF expectations to ensure alignment with protocol and regulatory requirements.
• Supports coordination of Investigational Products (IP), focusing on the documentation and tracking
• Tracks and reports on key study metrics (e.g., regulatory package status, TMF accuracy/completeness/quality, site statuses) and provides regular updates to leadership with proposed mitigation strategies.
• Supports inspection readiness and audit preparation by conducting internal reviews, preparing team members, and participating in mock audits to ensure a continuous state of readiness.
• Maintain and organize TMF, including identifying and resolving TMF gaps, ensuring documents are complete, accurate and inspection ready.
• Contributes or authors key study documents, including Informed Consent Form (ICF)/Assent, study plans, and study-related templates.
• Supports CRAs in monitoring visit execution by performing eISF reviews and providing TMF vs ISF reports to ensure completeness.
• Manages day-to-day interactions and deliverables for third-party vendors (e.g., central labs, imaging) to ensure adherence to study timelines.
• Reviews vendor-specific documentation for accuracy and ensures relevant records are filed in the TMF.
• Contributes to departmental operations and process improvements, including SOP authorship, development of templates and tools, and optimization of systems.
• Maintains and supports clinical systems (e.g., CTMS, Smartsheet) ensuring accuracy of metrics.
• Oversees study training compliance by developing and maintaining study training matrixes and curriculum maintenance.
• Manages Central IRB activities across programs, including submission oversight, tracking approvals, and maintaining cross-functional IRB trackers.
• Performs contractual management, PO management, invoice tracking, and site payments.
• Performs Protocol Deviation management, data review, medical review committee submission management, and ClinicalTrials.gov maintenance.
• Coordinates planning for Investigator Meetings and specialized Surgeon Training.

Qualifications

• Bachelor's degree in life sciences, healthcare, or related field (e.g., Biology, Nursing, Pharmacy).
• Minimum 2+ years of experience in clinical research or clinical operations.
• Strong understanding of regulatory requirements and guidelines governing clinical trial documentation (e.g., ICH-GCP, FDA regulations).
• Experience specifically within a pharmaceutical or biotechnology sponsor environment (given the internal focus of the role).

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $80,000 to $95,000 annually.

The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.