Clinical Project Associate

About OrganOx

OrganOx is an innovative organ technology company originating from the University of Oxford and now part of the Terumo Group. The firm pioneers normothermic machine perfusion (NMP) technology with its flagship device, metra®, used globally in liver transplants to extend preservation times and assess organ viability. Terumo Corporation operates worldwide providing healthcare solutions.

Position Summary

The Clinical Project Associate (CPA) supports clinical research by assisting study sites and the clinical team throughout multiple study phases, including initiation, enrollment, and closure. This role involves performing monitoring visits, maintaining documentation, ensuring compliance with regulations, and facilitating clear communications among stakeholders.

Primary Responsibilities

• Review clinical protocols, data collection methods, and training resources.
• Develop and evaluate study forms and documents such as nomination, screening, informed consent, and monitoring plans.
• Ensure compliance of investigator and site documentation with FDA and company standards.
• Maintain thorough and accurate study files, performing internal audits as needed.
• Assist study sites in IRB submissions, renewals, and ensure adherence to IRB requirements.
• Build and nurture relationships with investigators and sites to support clinical trials.
• Identify and resolve data discrepancies and regulatory issues by collaborating with site teams and clinical management.
• Report serious compliance issues and help implement corrective actions.
• Provide protocol and data collection training to site and field personnel, including investigators and sales representatives.
• Review submitted clinical data for completeness, accuracy, and scientific validity.
• Assist in developing clinical databases specific to studies.
• Address operational challenges and communicate solutions to project teams and sites.
• Conduct on-site and remote monitoring visits under guidance, applying FDA, ICH/GCP guidelines and company policies.
• Create and resolve accurate queries and follow-up action items per procedure.
• Prepare monitoring visit reports and follow-up letters, ensuring resolution of site issues.
• Contribute input to departmental process improvements and collaborate with other departments.
• Support additional trials as needed and adhere strictly to organizational SOPs, policies, and code of conduct.
• Assist management with audits, meetings, training, and quality initiatives.

Required Skills and Experience

• Knowledge or experience in transplant surgery or medical device clinical research preferred; capable of learning new therapeutic areas.
• Ability to maintain composure under pressure and manage shifting priorities effectively.
• Exceptional attention to detail and accuracy.
• Solid understanding of medical terminology.
• Strong organizational and time management skills.
• Excellent written and verbal communication skills.
• Proficient interpersonal skills for effective teamwork and independent work.
• Experience with MS Word, Excel, and database software.

Qualifications and Requirements

• Bachelor’s or higher degree in life sciences, nursing, or related health fields.
• Valid United States driver’s license.
• Minimum two years clinical research experience in medical devices, pharmaceutical industry, or CRO roles such as CRA or clinical trial assistant.
• Solid knowledge of FDA regulations and ICH/GCP standards applicable to clinical trials.
• Certification as Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) is desirable.
• Willingness to travel approximately 10% for training, meetings, monitoring, and seminars.
• Physical ability to communicate, sit extensively, and occasionally lift up to 50 pounds.
• Work environment is fully remote with collaboration across multiple time zones.

Additional Information

This position requires adherence to all job-related instructions and company policies. The job holder may be assigned additional tasks as directed by their manager.

Benefits

• Competitive salary with comprehensive benefits starting from day one including health, dental, vision, and disability coverage.
• Flexible spending accounts (FSAs).
• 401(k) retirement plan with employer matching after 90 days.
• Paid time off, holidays, and other leave benefits.
• Employee discounts and onsite wellness facility access.
• Supportive work-life balance culture and opportunities for continuous professional development.