Alira Health is a global healthcare consulting and technology company serving life sciences organizations. Its work spans research and clinical development, regulatory compliance, management consulting, patient engagement, and market access, with technology solutions designed to support life sciences research. The company emphasizes empathy, scientific excellence, patient outcomes, environmental sustainability, community involvement, and ESG initiatives.
Clinical Research Associate | Alira Health | Boston Hybrid
Clinical Research Associate supporting clinical trial monitoring for Alira Health across the Americas. The role focuses on protocol compliance, site quality, regulatory documentation, and study execution through remote and onsite visits.
United States
Massachusetts$115,000 – $135,000 / year
HybridFull-timeJuniorMiddleEnglish RequiredClinical ResearchDescription
- Monitor clinical trial sites and study activities.
- Provide oversight, leadership, and guidance for clinical trial management and execution.
- Maintain protocol compliance, quality standards, SOP adherence, timelines, and budgets.
- Review monitoring visit reports and conduct co-monitoring and evaluation visits.
- Complete investigator site visits on schedule.
- Coordinate cross-functional teams to resolve clinical trial monitoring issues.
- Support monitoring plans, training materials, ethics documentation, and site contract negotiations.
- Submit monthly billing information to the finance team.
- Manage study budgets and serve as the sponsor contact for stand-alone projects.
- Conduct qualification, initiation, interim, and close-out visits remotely and onsite.
- Prepare accurate monitoring reports covering site issues, resolutions, protocol deviations, study progress, and enrollment.
- Verify source documentation and CRF data integrity.
- Perform quality control and document verification for eTMF and TMF records.
- Track investigational product accountability.
- Review site regulatory binders.
- Maintain site communication on protocol and GCP compliance, patient accrual, and sponsor requests.
- Ensure adherence to ICH GCP, FDA regulations, and company or sponsor SOPs.
- Participate in internal, client, sponsor, scientific, and other meetings.
- Facilitate adverse event reporting and reconcile SAE reports with source records and CRFs.
- Resolve discrepant data queries with CRAs, CTCs, and data management teams.
- Identify site issues and develop practical resolution strategies.
- Prepare study sites for audits.
- Mentor and train CRAs and support new-hire onboarding.
- Contribute to CTMS development and maintenance.
- Balance competing priorities and complete additional assigned duties.
Requirements
- Build and maintain positive working relationships with sponsors, sites, and project teams.
- Manage monitoring activities independently.
- Apply a careful, thorough, and detail-oriented approach to quality.
- Organize work effectively and manage multiple priorities in a fast-paced environment.
- Prioritize tasks, manage time, and solve problems effectively.
- Demonstrate strong analytical, negotiation, meeting management, cross-functional collaboration, and leadership skills.
- Willingness to travel.
- Ability to manage stress effectively.
- Maintain a professional, trustworthy, and disciplined approach.
- Solve unstructured or ambiguous problems.
- Use the local language fluently in writing and speaking where monitoring activities are conducted.
- Communicate clearly and work effectively with customers and stakeholders.
- Use clinical trial management systems, clinical trial databases, and electronic data capture tools.
- Work independently as a self-starter within a collaborative, less structured team environment.
- Understand clinical research, ICH GCP, and applicable local regulations.
- Understand regulatory and ethical requirements.
- English proficiency.
- Bachelor of Science degree in Biology or Life Sciences.