Alira Health is searching for a permanent Senior CRA in The Netherland or Belgium. The Sr CRA is responsible for conducting site monitoring responsibilities, providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.
Requirements
- Provides guidance, oversight, and feedback to the CRA team
- Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed
- Ensures appropriate and timely investigator site visits
- Coordinates with cross-functional departments to facilitate negotiation/issue resolution
- Assists in development of study-specific Monitoring Plans and training presentations
- Assists in set up/collection of site specific ethics documents and site contract negotiation
- Provides monthly billing information to finance team
- Performs qualification, initiation, interim, and close-out visits
- Prepares monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
- Ensures integrity of CRF data through meticulous and thorough source document review and verification
- Performs quality control and verification of documents collected at sites for eTMF/TMF
- Conducts investigational product accountability
- Reviews site regulatory binder for required documents
- Maintains regular contact with study sites to ensure protocol/GCP compliance
- Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs
- Participates in internal, client/sponsor, scientific, and other meetings as required
- Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs
- Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data
- Proactively identifies site issues and develops problem-solving strategies for sites
- Conducts audit preparation at study sites as needed
- Works with other CRAs to maintain consistency and promote a collaborative team atmosphere
- Participates in internal, client/sponsor, scientific, and other meetings as required
- Assists in CRA new hire training and onboarding
- Performs CRA mentoring
- Collaborates with development and maintenance of Clinical Trial Management System (CTMS)
- Manages and resolves conflicting priorities to deliver on commitments
- Performs additional duties as assigned
Benefits
- Competitive salary
- Benefits package
- Opportunity to work with a global team
- Collaborative and dynamic work environment
