The Lead CRA is an important member of the Alira Health Clinical team, responsible for oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality.
Requirements
- Perform site monitoring visits
- Collaborate with cross-functional teams and CRAs
- Escalate quality issues or trends
- Conduct investigational product inventory and accountability
- Review Investigator Site File (ISF) for audit readiness
- Perform quality checks on regulatory documents
- Verify and review safety events
- Prepare accurate monitoring visit reports and communication logs
- Participate in internal, client/sponsor, scientific, and other meetings
- Work with other CRAs to maintain consistency and promote a collaborative team atmosphere
- Assist in set up/collection of site-specific ethics documents and site contract negotiation
- Provide monthly billing information to finance team
- Manage study budget and act as referent for the sponsor
- Perform CRA training and mentoring
- Oversee Clinical Research Associates (CRAs)
- Ensure CRAs are working with sites to drive, track and report on subject recruitment
- Provide protocol and study related training to assigned CRA
- Evaluate the quality and integrity of CRA performance
- Maintains oversight and accountability of monitoring visit reports
- Works closely with Project Managers, CRAs and Data Management to resolve CRF queries
- Collaborates with development, maintenance and training of the Clinical Trial Management System (CTMS) and Trial Master File (TMF)
- Prepares for, attends and presents during Investigator Meetings
- Conducts project specific CRA meetings and trainings
- May be mentored and assigned Project Management, or other operational tasks
- Assists in resourcing planning for upcoming and ongoing clinical trials
- Can support hiring potential new employees
- Can be responsible for CRA new hire training and onboarding
- Can conduct review of CRA timesheet reporting
- May participate and present in bid defense meetings
- May participate in audits and associated meetings, including preparation at study sites as needed
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Tuition Reimbursement
- Relocation Assistance
