Clinical Project Associate

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🔥 11 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

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OrganOx

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

OrganOx is a company dedicated to transforming organ preservation to improve outcomes in liver transplantation. Their flagship product, the OrganOx metra, is a fully automated device for the normothermic preservation of donor livers. This device enables the functional assessment of donor organs prior to transplantation, reduces early allograft dysfunction, and enhances transplantation logistics. The OrganOx metra keeps the donor liver perfused with oxygenated blood, medications, and nutrients at normal body temperature, preserving it in a functional state for up to 24 hours. By supporting transplant teams, OrganOx aims to increase the number of donor organs available for transplant and improve the health outcomes for transplant recipients.

📋 Description

• 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 OrganOx 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 OrganOx 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 OrganOx 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 OrganOx procedures. • Apply FDA regulations, ICH/GCP guidelines and OrganOx procedures to monitoring activities. • Create professional, accurate and succinct queries and action items per OrganOx procedures and follow queries and action items to resolution. • Complete Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per OrganOx 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, investigator meetings, training, continuous quality improvement, etc. • Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

🎯 Requirements

• Preferred demonstrated aptitude and knowledge in relevant therapeutic area (Transplant Surgery and/or medical device research) and ability to learn and integrate new or different therapeutic areas. • Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands. • High attention to detail and accuracy. • Proficient knowledge of medical terminology. • 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. • Must have a valid US driver’s license. • 2 years clinical research experience in medical device or pharmaceutical industry or CRO as a CRA, clinical trial assistant, research site role or similar role. • Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials. • 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. • Physical Demands: While performing the duties of this job, the employee is regularly required to talk and hear. • The position may require sitting for significant periods of the day while working on the computer. • The employee must occasionally lift or move items weight up to 50 pounds. • Work Environment: This is a work-from-anywhere, remote job wherein meetings and collaborations can occur across multiple time zones.

🏖️ Benefits

• We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. • Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. • OrganOx supports work-life balance and provides opportunities for ongoing professional development