Clinical Research Associate

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.

Primary Responsibilities:
• 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

Secondary Responsibilities:
• 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

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