Clinical Project Associate

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Support the evaluation of protocols, data collection techniques, and training materials.

• Assist in the creation and assessment of study-related documents, including nomination and screening forms, monitoring plans, informed consent, and study agreements.

• Ensure that documentation from investigators and study sites aligns with FDA and OrganOx standards.

• Prepare and maintain thorough and accurate in-house study files, which include original study documents, training materials, inventory, site regulatory documentation, and correspondence throughout the study duration.

• Conduct audits of in-house study files to ensure compliance with departmental standards.

• Aid sites in the IRB submission process, assist with IRB renewals, and monitor continuing IRB renewals, ensuring site adherence to IRB requirements.

• Support OrganOx in establishing and fostering professional relationships with investigators and study sites for the assigned study.

• Exhibit critical thinking to identify discrepancies in data, compliance issues, and/or regulatory concerns, collaborating with site staff and project teams for resolution.

• Recognize and report serious compliance issues to clinical management and take part in the development of action plans.

• Provide training to site and field personnel regarding protocol requirements.

• Educate site coordinators, investigators, and field clinical staff on collecting data promptly while adhering to protocol standards.

• Support site coordinators, investigators, field clinical staff, and sales representatives in the appropriate collection of data.

• Assess data submitted to OrganOx for completeness and accuracy.

• Review aggregate clinical data for scientific validity and work with the project team to address discrepancies.

• Assist in the creation and execution of a study-specific clinical database.

• Identify logistical and operational challenges and collaborate with clinical management to devise solutions, effectively communicating these solutions to field and site personnel.

• With oversight, carry out on-site and remote monitoring visits, as well as centralized monitoring, in accordance with timelines and the monitoring plan, following OrganOx procedures.

• Apply FDA regulations, ICH/GCP guidelines, and OrganOx procedures during monitoring activities.

• Generate professional, precise, and concise queries and action items following OrganOx protocols, following these queries and action items to resolution.

• Complete Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters according to OrganOx procedures, collaborating with sites to resolve action items between monitoring visits.

• Contribute to departmental decisions regarding processes and procedures.

• Collaborate with other departments as necessary.

• Provide support and assistance to team members in the completion of other trials as needed.

• Comply with and demonstrate expertise in departmental SOPs and policies, escalating procedural inconsistencies to the Manager.

• Assist the Manager with team, department, and study-related projects as required, including audits, investigator meetings, training, and continuous quality improvement initiatives.

• Uphold the letter and spirit of OrganOx’s Code of Conduct along with all other company policies.

⛳️ Requirements

• Preferred demonstrated aptitude and knowledge in relevant therapeutic areas (Transplant Surgery and/or medical device research) with the capacity to learn and integrate new therapeutic areas.

• Proven ability to remain composed in challenging situations and adapt to shifting priorities and competing demands.

• Exceptional attention to detail and accuracy.

• Proficient understanding of medical terminology.

• Excellent time management and organizational capabilities.

• Strong professional writing and oral communication skills.

• Outstanding interpersonal skills.

• Ability to work independently as well as collaboratively within a team.

• Experience with word processing, spreadsheet, and database applications (e.g., MS Word and Excel).

• Bachelor's or Graduate degree in a life science, nursing, or other health-related disciplines.

• Must possess a valid US driver's license.

• A minimum of 2 years of clinical research experience in the medical device or pharmaceutical industry or CRO, in roles such as CRA, clinical trial assistant, research site role, or similar positions.

• Strong working knowledge and understanding of FDA regulations and ICH/GCP guidelines governing clinical trials.

• Current certification as a Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) is preferred.

• Willingness to travel 10% of the time for training, investigator meetings, monitoring responsibilities, corporate meetings, and educational seminars.

• Physical Demands: The employee is frequently required to talk and hear while performing job duties.

• The position may require prolonged sitting while working on a computer.

• The employee must occasionally lift or move items weighing up to 50 pounds.

• Work Environment: This is a remote work-from-anywhere position, with meetings and collaborations across multiple time zones.

🏝️ Benefits

• We provide competitive compensation and a comprehensive benefits package available from day one, which includes 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, additional leave benefits, employee discounts, and access to our onsite wellness facility.

• OrganOx promotes work-life balance and offers ongoing opportunities for professional development.