[Remote] Clinical Project Associate

Note: The job is a remote job and is open to candidates in USA. OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The Clinical Project Associate (CPA) will work with research sites and the clinical research team to facilitate the successful conduct of clinical investigations, ensuring compliance with federal regulations and OrganOx policies.

Responsibilities

• 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

Skills

• 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
• Ability to travel 10% of the time for training, investigator meetings, monitoring responsibilities, corporate meetings, and educational seminars
• 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)
• Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP) is preferred
• 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

Benefits

• 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
• Additional leave benefits
• Employee discounts
• Access to our onsite wellness facility
• Supports work-life balance
• Opportunities for ongoing professional development

Company Overview