Job Duties
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 Management team immediately, and communicate non-critical issues in a timely manner; ensure the 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 company/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
Experience & Skills Required
- 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