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Alira Health · 1 day ago

Clinical Research Associate

Framingham, MA

Full-time

Hybrid

Entry, Mid Level

2+ years exp

Alira Health is a global team dedicated to innovation and initiative, encouraging collaboration across physical walls and time zones. The Clinical Research Associate plays a key role in conducting site monitoring for clinical trials, ensuring protocol compliance, and assisting with various site-related issues.

BiotechnologyConsultingHealth Care

No H1B

Responsibilities

Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits

Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status

Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs

Ensures integrity of CRF data through meticulous and thorough source document review and verification

Conducts investigational product accountability

Reviews regulatory binder for required documents

Works closely with in-house CRAs and data management to resolve queries on discrepant data

Proactively identifies site issues and develops problem-solving strategies for sites

Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests

Conducts audit preparation at study sites as needed

Works with other CRAs to maintain consistency and promote a collaborative team atmosphere

Manages and resolves conflicting priorities to deliver on commitments

Complies with ICH GCP guidelines, FDA regulations, and company SOPs

Participates in industry and client meetings

Performs additional duties as assigned

Qualification

Clinical research experienceGCP complianceMS Office SuiteProblem-solvingEnglish proficiencyCommunication skillsOrganizational skillsDetail-orientedTeam collaboration