Clinical Research Associate
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Job Description
Clinical Research Associate monitoring clinical trials for Alira Health’s global research team. Ensuring protocol compliance, site quality, data integrity, and regulatory adherence.
Responsibilities:
- Conduct site monitoring responsibilities for clinical trials
- Provide oversight, leadership, and guidance in clinical-trial management and execution
- Ensure protocol compliance and quality
- Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
- Ensure timely investigator site visits
- Coordinate cross-functional departments to resolve clinical-trial monitoring issues
- Assist with study-specific Monitoring Plans and training presentations
- Assist with ethics-document collection and site contract negotiation
- Provide monthly billing information to Finance
- Manage study budgets and act as sponsor referent for stand-alone projects
- Perform qualification, initiation, interim, and close-out visits remotely and onsite
- Prepare monitoring visit reports documenting site problems, resolutions, protocol deviations, study progress, and enrollment
- Review and verify source documents and CRF data
- Perform quality control and verification of eTMF/TMF documents
- Conduct investigational product accountability
- Review site regulatory binders
- Maintain contact with study sites regarding protocol/GCP compliance, accrual, and sponsor requests
- Ensure compliance with ICH GCP, FDA regulations, and SOPs
- Facilitate adverse-event reporting and reconcile SAE reports with source documentation and CRFs
- Resolve discrepant-data queries with in-house CRAs/CTC and Data Management
- Identify site issues and develop problem-solving strategies
- Conduct audit preparation at study sites
- Assist with CRA training and onboarding; mentor CRAs
- Collaborate on CTMS development and maintenance
- Manage conflicting priorities and deliver commitments
Requirements:
- 2+ years monitoring experience
- 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 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 the local language, written and verbal, in the country where monitoring activities are performed
- Excellent communication and interpersonal skills with customer service orientation
- Good computer skills, including clinical trial management systems, clinical trial databases, and electronic data capture
- Knowledge of clinical research, ICH GCP, and local regulations
- Knowledge of regulatory and ethical requirements
- Bachelor's degree in Biology, Life Sciences, or equivalent listed education
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