Clinical Trial Assistant

About Kelonia Therapeutics

Kelonia Therapeutics is driven by an ambitious mission to revolutionize genetic medicine, aiming to deliver life-saving therapies to patients in need. Our team of pioneers in cell and gene therapy is guided by exceptional scientific founders, fostering a culture rooted in rigor, collaboration, and mutual care. Joining us means being part of a transformative journey that impacts patients' lives and the future of medicine.

Role Overview

We seek a dedicated Associate Manager, Clinical Trial Assistant (CTA) within our Clinical group to support early-phase clinical trials in a fast-moving, innovative cell and gene therapy setting. This role demands strong operational leadership, meticulous documentation practices, and proactive cross-functional collaboration to facilitate the successful execution of clinical studies.

Key Responsibilities

• Assist in planning and managing clinical trials from initiation through closure.
• Track and maintain study timelines, milestones, and critical deliverables such as site activations and enrollment progress.
• Develop and monitor study trackers, dashboards, and status reports to ensure transparency and accountability.
• Coordinate logistics including vendor activities, clinical supply management, and documentation for meetings.
• Take primary responsibility for the electronic Trial Master File (eTMF), ensuring completeness, accuracy, and compliance with SOPs and regulations.
• Conduct ongoing quality control to verify TMF contents and maintain inspection readiness.
• Support internal audits and external regulatory inspections.
• Assist with site start-up tasks, including reviewing and tracking essential documents like CVs, licenses, 1572s, and informed consent forms.
• Help prepare and submit regulatory and ethics committee documents, including Institutional Review Board (IRB) submissions and amendments.
• Monitor site activation status and address open issues promptly.
• Manage vendor deliverables, timelines, and documentation, escalating risks when necessary.
• Facilitate coordination of investigator meetings, site communications, and study-related trainings.
• Collaborate with Clinical Development Operations, Regulatory, Quality, Data Management, and Bioanalytical teams.
• Organize study team meetings, prepare agendas, and track follow-up actions.
• Identify and mitigate operational risks to preserve study timelines.
• Ensure compliance with ICH-GCP guidelines, company SOPs, and all relevant regulatory requirements.
• Support safety reporting documentation and tracking as required.
• Contribute to ongoing improvements in clinical operations processes and systems.

Qualifications and Experience

• Bachelor’s degree in life sciences or a related discipline.
• 3 to 6+ years of clinical research or clinical operations experience within biotechnology, pharmaceutical, or CRO environments.
• Prior involvement in early-phase clinical trials; experience in cell and gene therapy preferred.
• Proficiency in clinical systems such as eTMF and Electronic Data Capture (EDC).
• Expertise in document management and quality control of Trial Master File content.
• Strong skills in Microsoft Office applications including Excel, PowerPoint, and Word.
• Exceptional organizational capabilities with a keen attention to detail.
• A strong sense of ownership and responsibility in a dynamic setting.
• Ability to handle multiple tasks concurrently and work independently with minimal supervision.
• Effective communication and teamwork skills, engaging both internal and external stakeholders.
• A proactive problem-solving approach focused on quality and execution.

Compensation and Benefits

The anticipated annual compensation ranges from $109000 to $144000, and the final offer will reflect several individual factors such as experience, skills, and educational background.

Kelonia values work-life balance and personal growth, offering flexible time off, adaptable scheduling aligned with team goals, comprehensive benefits including health and commuter provisions, and on-site amenities such as free parking, a modern gym, and food services within a collaborative and inclusive environment.

Diversity and Inclusion

Kelonia Therapeutics is committed to equal employment opportunities and prohibits discrimination based on race, color, gender identity, sexual orientation, age, religion, ethnicity, disability, veteran status, or any legally protected category.

Additional Information

We only accept resumes directly from candidates. We incorporate artificial intelligence tools in our recruitment process to assist in evaluating applications, but all final hiring decisions are made by human recruiters. For questions on data processing during recruitment, candidates can reach out for more details.