Clinical Project Associate

About the role

OrganOx is a commercial stage organ technology company focused on improving patient outcomes for acute and chronic organ failure. Founded in 1921, Terumo Corporation, which owns OrganOx, aims to contribute to society through healthcare by providing comprehensive solutions globally.

Responsibilities

• Assist in the review of protocols, data collection methods, and training materials
• Develop and review study documents, including nomination and screening forms, monitoring plan, informed consent, and study agreements
• Ensure documentation from investigators and study sites meet FDA and OrganOx requirements
• Prepare and maintain complete and accurate in-house study files, including original study documents, training documents, inventory, site regulatory documentation, and correspondence
• Audit in-house study files for compliance to departmental standards
• Audit sites with IRB submission process and assist with IRB renewal process
• Support OrganOx in maintaining professional relationships with investigators and study sites
• Identify and report serious compliance issues and participate in implementing action plans
• Train site and field personnel in protocol requirements and data collection
• Review data submitted to OrganOx for completeness and accuracy
• Interface with project team to resolve discrepancies in aggregate clinical data
• Identify and address logistical and operational issues
• Conduct on-site and remote monitoring visits and centralized monitoring
• Create professional, accurate, and succinct queries and action items
• Complete Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters
• Provide input on departmental decisions and assist team members
• Adhere to and demonstrate proficiency in implementing departmental SOPs and policies
• Escalate procedural discrepancies to Manager
• Support and assist team members in completing other trials
• Participate in audits, investigator meetings, training, continuous quality improvement, etc.

Requirements

• Demonstrated aptitude and knowledge in relevant therapeutic area (Transplant Surgery and/or medical device research)
• High attention to detail and accuracy
• Excellent time management and organizational skills
• Excellent professional writing and oral communication skills
• Excellent interpersonal skills
• Ability to work independently as well as part of a team
• Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)
• Bachelor's or Graduate degree in a life science, nursing, or other health-related disciplines
• Valid US driver's license
• Two years clinical research experience in medical device or pharmaceutical industry or CRO as a CRA, clinical trial assistant, research site role, or similar role
• Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP) is preferred
• Ability to travel 10% of the time for training, investigator meetings, monitoring responsibilities, corporate meetings, and educational seminars

Qualifications

• Physical Demands: Regularly required to talk and hear, sit for significant periods of the day while working on the computer, lift or move items up to 50 pounds, and work across multiple time zones
• Work Environment: Work-from-anywhere, remote job

Benefits

• Competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts
• 401(k)-retirement plan with company matching after 90 days
• Paid time off, holidays, and additional leave benefits
• Employee discounts and access to onsite wellness facility
• Opportunities for ongoing professional development