Clinical Project Associate

ABOUT ORGANOX:

Organ Ox is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. Organ Ox is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia.

It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

The Clinical Project Associate (CPA) is responsible for working with research sites and the clinical research team to facilitate the successful and timely conduct of clinical investigation(s), building relationships, and effectively communicating ideas and results. The CPA participates in most phases of ongoing clinical investigation(s) including Study Initiation, Enrollment, and Study Closure. The CPA contributes to ongoing studies by performing on-site monitoring visits and remote monitoring visits (with oversight);

centralized monitoring, following up on monitoring visit action items; maintaining in-house study files; providing day-to-day study management and site support; interfacing with site coordinators, investigators, field clinical staff, and other company representatives. The CPA ensures study and site compliance with applicable federal regulations and Organ Ox policies and procedures.

This is a remote position in the United States.

• Assist in the review of protocols, data collection methods and training materials
• Assist in the development and review of study documents, including nomination and screening forms, monitoring plan, informed consent and study agreements
• Ensure that documentation from investigators and study sites meets FDA and Organ Ox requirements
• Prepare and maintain complete and accurate in-house study files, including original study documents, training documents, inventory, site regulatory documentation, and correspondence during the course of the study. Audit in-house study files for compliance to departmental standards
• Assist sites with IRB submission process. Assist sites with IRB renewal process and tracks continuing IRB renewals. Ensure site compliance with IRB requirements
• Support Organ Ox in maintaining current and developing new professional relationships with investigators and study sites for assigned study
• Demonstrate critical thinking to recognize data discrepancies, compliance, and/or regulatory issues and interface with site staff and project team for resolution
• Identify and report serious compliance issues to clinical management and participate in implementing action plans
• Provide training to site and field personnel in protocol requirements
• Provide training to site coordinators, investigators, and field clinical staff in collecting data in a timely manner that meets the protocol requirements. Assist site coordinators, investigators, field clinical staff, and sales representatives in collecting data appropriately
• Review data submitted to Organ Ox for completeness and accuracy
• Review aggregate clinical data for scientific validity and interface with project team to resolve discrepancies
• Assist in the development and implementation of a study-specific clinical database
• Identify logistical and operational issues and work with clinical management to develop solutions. Effectively communicates solutions to field and site personnel
• With oversight, conduct on-site and remote monitoring visits as well as centralized monitoring within timelines and according to the monitoring plan and Organ Ox procedures. Apply FDA regulations, ICH/GCP guidelines and Organ Ox procedures to monitoring activities
• Create professional, accurate and succinct queries and action items per Organ Ox procedures and follow queries and action items to resolution
• Complete Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per Organ Ox procedures and work with sites to resolve action items between monitoring visits
• Provide input on departmental decisions related to process and procedures
• Interface with other departments as necessary
• Provide support and assistance to team members in completing other trials when necessary
• Adhere to and demonstrate proficiency in implementing departmental SOPs and policies. Escalate procedural discrepancies to Manager
• Assist the Manager with team, department and study related projects as requested including audits,…