Clinical Research Associate

Alira Health · Framingham, MA · 6 mo ago

AnalystFull-time

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.

Ability to travel
Proven ability to be careful, thorough, and detail-oriented
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
Self-starter who thrives in a collaborative, yet less structured team environment
Ability to problem-solve unstructured or ambiguous challenges
Strong command of English, both written and verbal
Excellent communication and interpersonal skills with customer service orientation
Proficient with MS Office Suite, particularly Word and Excel

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