Responsibilities:
- Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan
- Participate in Investigator Meetings, CRA and Study Coordinator training sessions, and assist sites with study-related questions as needed.
- Confirming adherence to all FDA, ICH-GCP and local regulations
- Ensuring the completion and collection of regulatory documents
- Performing data verification of source documents
- Participating in budget negotiation and follow-up where applicable
- Mentoring junior team members as required
Qualifications:
- Therapeutic experience in any discipline, e.g. Oncology, Infectious disease, Neurology
- Minimum 2 years CRA monitoring experience
- Life-science related degree
- Experience with clinical trial information systems
- Ability to travel up to 60% on average
