Cara Therapeutics employs various CROs to assist in the conduct of their clinical trials. The Oversight CRA (OCRA) will oversee the performance of the CRO CRAs and serve as a second set of eyes at the investigational sites. The OCRA may also co-monitor and/or conduct independent monitoring visits, and will help with various aspects of the clinical trial process as needed (see Secondary Responsibilities below). This position will be a 6-month contract position with the potential of permanent hire.
• Conduct oversight visits to assess CRO CRA and Investigational Site performance
• Use experience and knowledge of ICH/GCP guidelines, protocols, Investigator’s Brochure, etc to identify issues and recommend solutions
• Escalate critical issues to the Cara Management team immediately, and communicate non-critical issues in a timely manner; ensure the Cara and CRO team are made aware of any trends that may affect multiple study sites and/or the study as a whole
• Write oversight visit reports, providing feedback on identified issues, actions taken and/or proposed solutions.
• Follow-up on identified issues by conducting additional oversight visits as needed and/or working with the CRO CRA and Cara/CRO management teams as needed to provide resolution
• Re-train CRO CRAs and/or sites as needed
• Provide co-monitoring assistance to CRO CRAs
• Conduct pre-study visits, initiation visits, monitoring visits and/or close-out visits
• Assist in study document creation/revision
• Create training materials, conduct team trainings and/or present at Investigator Meetings
• Create, maintain, and/or review spreadsheets and data listings
• Conduct file audits
• 5+ years of experience as a Clinical Research Associate
• Therapeutic and/or clinical experience in chronic kidney disease and dialysis preferred.
• Therapeutic and/or clinical experience in patient reported outcome, liver disease, and/or dermatological condition would be an advantage
• Ability to work across multiple trials and multiple therapeutic indication
• Ability to travel approximately 60-85%, regionally as feasible but across the US as needed
• Detail-oriented with strong communication skills (oral and written) and ability to prepare accurate monitoring visit report quickly
• Ability to be flexible and a team player is a must
• Position available immediately