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Clinical Research Associate - Massachusetts Remote
Monitor clinical trials for Alira Health’s global research team. Support protocol compliance, site quality, data integrity, and regulatory adherence.
संयुक्त राज्य
मैसाचुसेट्स$1,10,000 – $1,30,000 / वर्ष
रिमोटपूर्णकालिकजूनियरमध्य स्तरआवश्यक भाषा: अंग्रेज़ीनैदानिक अनुसंधानविवरण
- Monitor clinical trial sites and support study oversight.
- Provide leadership and guidance across clinical trial management and execution.
- Maintain protocol compliance and study quality.
- Review monitoring visit reports and complete co-monitoring and evaluation visits when needed.
- Ensure investigator site visits occur on schedule.
- Coordinate with cross-functional teams to resolve clinical trial monitoring issues.
- Support study-specific monitoring plans and training presentations.
- Assist with ethics document collection and site contract negotiations.
- Submit monthly billing information to Finance.
- Manage study budgets and serve as sponsor referent for standalone projects.
- Conduct qualification, initiation, interim, and close-out visits remotely and onsite.
- Document site issues, resolutions, protocol deviations, study progress, and enrollment in monitoring visit reports.
- Review and verify source documents and CRF data.
- Perform quality control and verification of eTMF/TMF documentation.
- Track investigational product accountability.
- Review site regulatory binders.
- Communicate with study sites about protocol and GCP compliance, accrual, and sponsor requests.
- Maintain compliance with ICH GCP, FDA regulations, and SOPs.
- Facilitate adverse-event reporting and reconcile SAE reports against source documentation and CRFs.
- Resolve discrepant-data queries with in-house CRAs/CTC and Data Management.
- Identify site issues and develop practical resolution strategies.
- Prepare study sites for audits.
- Support CRA training and onboarding and mentor CRAs.
- Contribute to CTMS development and maintenance.
- Balance competing priorities while meeting commitments.
आवश्यकताएँ
- At least two years of clinical trial monitoring experience.
- Ability to build and maintain positive relationships with sponsors, sites, and project team members.
- Ability to manage monitoring activities independently.
- Quality-focused approach with proven care, thoroughness, and attention to detail.
- Strong organizational skills and the ability to multitask effectively in a fast-paced environment.
- Ability to prioritize tasks, manage time, and solve problems.
- Strong analytical, negotiation, meeting-management, cross-functional collaboration, and leadership skills.
- Willingness and ability to travel.
- Ability to manage stress effectively.
- Professional, trustworthy, and disciplined working style.
- Ability to solve unstructured or ambiguous problems.
- Strong written and verbal command of the local language in the country where monitoring activities are performed.
- Excellent communication and interpersonal skills with a customer-service orientation.
- Proficiency with computers, including clinical trial management systems, clinical trial databases, and electronic data capture tools.
- Knowledge of clinical research, ICH GCP, and applicable local regulations.
- Knowledge of regulatory and ethical requirements.
- Bachelor’s degree in Biology, Life Sciences, or equivalent education.
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