Clinical Project Associate

About OrganOx

OrganOx is a commercial-stage organ technology company focused on enhancing outcomes for patients with acute and chronic organ failure. Founded in 2008 as a University of Oxford spin-out and now part of the Terumo Group, OrganOx pioneered normothermic machine perfusion (NMP). Their flagship product, the metra®, is utilized internationally, having supported over 7,000 liver transplants by maintaining donor livers metabolically active outside the body, allowing for longer preservation and functional assessment prior to transplantation, increasing organ availability. Terumo Corporation, established in 1921, operates in over 160 countries, providing healthcare solutions in therapeutic procedures, hospital operations, and life sciences.

Position Overview

The Clinical Project Associate (CPA) plays a pivotal role in collaborating with research sites and internal clinical teams to ensure the efficient and timely execution of clinical trials. The CPA engages in phases such as study initiation, enrollment, and closure, performing onsite and remote monitoring visits with oversight, centralized monitoring, managing in-house documentation, and supporting study compliance with FDA regulations and company policies. This is a remote position based in the United States.

Key Responsibilities

• Support review and development of protocols, data collection tools, and training content.
• Assist in preparing and reviewing study documentation like nomination forms, screening forms, monitoring plans, consent forms, and study agreements.
• Ensure investigators’ and sites’ documentation comply with FDA and OrganOx standards.
• Maintain accurate and complete in-house study files including originals, training records, inventory, regulatory documents, and correspondence; audit for compliance.
• Assist sites with Institutional Review Board (IRB) submissions and renewals, ensuring adherence to IRB requirements.
• Facilitate and maintain professional relationships with investigators and study sites.
• Apply critical thinking to identify data inconsistencies, compliance issues, and collaborate with project teams and site staff for resolution.
• Report major compliance concerns to clinical management and help implement corrective actions.
• Provide training to site coordinators, investigators, field clinical staff, and sales representatives on protocol adherence and timely data collection.
• Review data submissions for completeness and scientific validity, addressing discrepancies with project teams.
• Contribute to clinical database development and implementation.
• Address operational challenges by collaborating with clinical management to develop and communicate solutions.
• Conduct onsite and remote monitoring visits with oversight, ensuring adherence to FDA and GCP guidelines and company procedures.
• Prepare clear and concise queries and monitoring visit documentation and follow through to resolution.
• Provide input on departmental procedures and policies, and collaborate across departments as needed.
• Support team members on additional trials, assist with audits, investigator meetings, training, and quality improvement initiatives.
• Adhere to OrganOx’s code of conduct, policies, procedures, and escalate discrepancies appropriately.

Required Qualifications and Skills

• Bachelor’s or graduate degree in life sciences, nursing, or health-related fields.
• Minimum of 2 years clinical research experience in medical device, pharmaceutical industry, or CRO environments, preferably in roles such as CRA, clinical trial assistant, or site research staff.
• Valid U.S. driver’s license and willingness to travel up to 10% for training and meetings.
• Proven knowledge and ability to apply FDA regulations and ICH/GCP guidelines to clinical trials.
• Certification as a Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) preferred.
• Strong attention to detail, accurate documentation, and high organizational skills.
• Excellent communication skills, both written and verbal, with effective interpersonal abilities.
• Ability to work autonomously and collaboratively in a team setting.
• Proficiency with common office software including MS Word and Excel.
• Familiarity with medical terminology and transplant surgery or medical device research is advantageous.
• Capability to maintain composure under pressure and adapt to shifting priorities and competing demands.
• Physical capability to occasionally lift up to 50 pounds and sit for extended periods during computer work.

Work Environment

This role is fully remote within the U.S., involving collaboration across multiple time zones. The position requires participation in virtual meetings and occasional onsite visits as needed.

Employee Benefits

• Competitive salary and comprehensive benefits effective from the first day, including health, dental, vision, disability coverage, and flexible spending accounts.
• 401(k) retirement plan with company matching after 90 days of employment.
• Generous paid time off, holidays, and additional leave options.
• Employee discounts and access to onsite wellness facilities.
• Commitment to work-life balance and opportunities for professional growth and development.

Note

Job duties may evolve, and the clinical project associate may be required to perform additional tasks as reasonably assigned by management.