Clinical Research Associate
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Job Description
Clinical Research Associate monitoring clinical trials for global healthcare company Alira Health. Ensuring site compliance, data integrity, regulatory adherence, and study quality through remote and onsite visits.
Responsibilities:
- Conduct site monitoring responsibilities for clinical trials
- Provide oversight, leadership, and guidance in the management and execution of clinical trials
- Ensure protocol compliance and quality
- Work with Lead CRAs, Senior CRAs, in-house CRAs, Associate Director of Clinical Monitoring, and Project Managers
- Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
- Review monitoring visit reports and conduct co-monitoring and evaluation visits
- Ensure appropriate and timely investigator site visits
- Coordinate cross-functional departments to resolve clinical trial monitoring issues
- Assist with study-specific Monitoring Plans and training presentations
- Set up and collect site-specific ethics documents and assist with site contract negotiation
- Provide monthly billing information to the finance team
- Manage study budgets and act as sponsor referent for stand-alone projects
- Perform qualification, initiation, interim, and close-out visits remotely and onsite
- Prepare accurate and timely monitoring visit reports
- Review source documents and verify CRF data integrity
- Perform quality control and verification of eTMF/TMF documents
- Conduct investigational product accountability
- Review site regulatory binders
- Maintain contact with study sites, assess patient accrual, and respond to sponsor requests
- Ensure compliance with ICH GCP, FDA regulations, and company/sponsor 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 onboarding, training, and mentoring
- Collaborate on the development and maintenance of the Clinical Trial Management System (CTMS)
- Manage conflicting priorities and perform additional assigned duties
Requirements:
- 2+ years monitoring experience required
- Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
- Ability to autonomously manage monitoring activities
- Quality focused; careful, thorough, and detail-oriented
- Strong organizational skills and ability to multi-task in a fast-paced environment
- Ability 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
- Self-starter able to thrive in a collaborative, less structured team environment
- Knowledge of clinical research, ICH GCP, and local regulations
- Knowledge of regulatory and ethical requirements
- English language
- Bachelor of Science (BS) in Biology or Life Sciences
Benefits:
- Remote and onsite work options for monitoring visits
- Regular employment contract
- Global, collaborative work environment
- Opportunities for CRA mentoring and training
- Professional development through participation in internal, client/sponsor, scientific, and other meetings
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