Note: The job is a remote job and is open to candidates in USA. Alira Health is seeking a Clinical Research Associate to join its global clinical team. The role independently conducts and oversees clinical trial site monitoring, ensuring protocol compliance, data integrity, regulatory adherence, and study quality while collaborating with clinical, project management, sponsor, and site teams.
Responsibilities
- Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements
- Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed
- Ensures appropriate and timely investigator site visits
- Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues
- Assists in development of study-specific Monitoring Plans and training presentations as required
- Assists in set up/collection of site specific ethics documents and site contract negotiation as required
- Provides monthly billing information to finance team as required
- For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor
- Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits
- Prepares consistently accurate and timely 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, assesses patient accrual rates, and responds to sponsor requests
- 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
Skills
- * EU: Graduation in a scientific health field
- * EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
- * Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
- * Ability to autonomously manage monitoring activities
- * Quality focused; Proven ability to be careful, thorough, and detail-oriented
- * Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
- * Able to manage priorities, organize time and solve problems
- * Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- * Ability to travel
- * Ability to manage stress
- * Professional, trustworthy and disciplined
- * Ability to problem-solve unstructured or ambiguous challenges
- * Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
- * Excellent communication and interpersonal skills with customer service orientation
- * Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
- * Self-starter who thrives in a collaborative, yet less structured team environment
- * Knowledge of clinical research, ICH GCP and local regulations
- * Knowledge of Regulatory and Ethical requirements
- * EU: Adequate English
- English
- Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences
Benefits
- Remote work
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