Clinical Trial Assistant

Kelonia Therapeutics • Boston, MA

2d • Onsite

About The Position

At Kelonia Therapeutics, our ambitions are bold: to dramatically expand the benefit and reach of genetic medicines. Our goal is to change what’s possible for genetic medicine by building the capabilities, experience, and commitment to bring life-saving medicine to every patient in need. We are a human-first company, driven by a mission to develop transformative genetic medicines for patients and their loved ones. We have brought together pioneers in cell and gene therapy, guided by extraordinary scientific founders and a team committed to turning breakthrough science into real-world impact. As we grow, we are building a culture that values rigor, collaboration, and care for one another. Are you ready to be a part of our remarkable journey? We're looking for someone exceptional to join our growing team as an Associate Manager, Clinical Trial Assistant (CTA) in the Clinical group. to support the execution of early-phase clinical trials in a fast-paced, cell and gene therapy environment. This role is critical to ensuring the successful delivery of clinical studies through strong operational ownership, rigorous documentation practices, and proactive cross-functional coordination. This isn't just a job; it's an opportunity to contribute to groundbreaking therapies, to be part of a company's inception, and to make a transformative impact on patients' lives. If you're passionate about scaling a company from the ground up, making a real difference, and shaping the inclusive culture we're proud of, this opportunity is tailor-made for you. Join us and be a driving force in achieving excellence in viral engineering.

Requirements

• Bachelor’s degree in life sciences or related field
• 3–6+ years of experience in clinical research or clinical operations (biotech, pharma, or CRO)
• Experience supporting early-phase clinical trials; exposure to cell and gene therapy is a plus
• Experience with clinical systems (e.g., eTMF, EDC, etc.)
• Strong document management and TMF quality control experience
• Proficiency in Microsoft Office (Excel, PowerPoint, Word)
• Exceptional organizational skills and attention to detail
• Strong sense of ownership and accountability in a fast-paced, evolving environment
• Ability to manage multiple priorities and work independently with minimal oversight
• Effective communication and collaboration across internal and external stakeholders
• Proactive problem-solving mindset with a focus on execution and quality

Responsibilities

• Support the planning and execution of clinical trials from study start-up through close-out
• Maintain and track study timelines, milestones, and deliverables (e.g., site activation, enrollment, data cleaning)
• Develop and manage study trackers, dashboards, and status reports to ensure visibility and accountability
• Coordinate study logistics, including vendor activities, clinical supplies, and meeting documentation (as applicable)
• Serve as a primary owner of the electronic Trial Master File (eTMF), ensuring documents are complete, accurate, and contemporaneous
• Perform ongoing quality control (QC) reviews of TMF content and ensure compliance with internal SOPs and regulatory requirements
• Maintain continuous inspection readiness and support internal audits and regulatory inspections
• Support site start-up activities, including collection, review, and tracking of essential documents (e.g., CVs, licenses, 1572s, ICFs)
• Assist in preparation and submission of regulatory and ethics documents (e.g., IRB/EC submissions and amendments)
• Track site activation progress and ensure timely resolution of outstanding items
• Track vendor deliverables, timelines, and documentation; escalate risks as appropriate
• Support coordination of investigator meetings, site communications, and study-related training logistics
• Partner cross-functionally with Clinical Development Operations, Regulatory, Quality, Data Management, and Bioanalytical teams
• Coordinate study team meetings, agendas, and follow-ups to ensure alignment and progress
• Proactively identify operational risks and propose solutions to maintain study timelines
• Ensure adherence to ICH-GCP, company SOPs, and applicable regulatory requirements
• Support safety reporting documentation and tracking, as needed
• Contribute to continuous improvement of clinical operations processes and systems

Benefits

• Flexible Time Off
• flexible scheduling
• health insurance
• commuter benefits
• on-site perks
• free parking
• state-of-the-art gym
• food hall

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level