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Alira Health · 4 months ago

Senior Clinical Research Associate

Verona, KY

Full-time

Onsite

Senior Level

Alira Health is a global team dedicated to innovation and collaboration. They are seeking a Senior Clinical Research Associate (CRA) who will conduct site monitoring for clinical trials and provide oversight to ensure compliance and quality throughout the process.

BiotechnologyConsultingHealth Care

Responsibilities

Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements

Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed

Ensures appropriate and timely investigator site visits

Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues

Assists in development of study-specific Monitoring Plans and training presentations as required

Assists in set up/collection of site specific ethics documents and site contract negotiation as required

Provides monthly billing information to finance team as required

For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor

Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits

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

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

Performs quality control and verification of documents collected at sites for eTMF/TMF

Conducts investigational product accountability

Reviews site regulatory binder for required documents

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

Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs

Participates in internal, client/sponsor, scientific, and other meetings as required

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

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

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

Conducts audit preparation at study sites as needed

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

Participates in internal, client/sponsor, scientific, and other meetings as required

Assists in CRA new hire training and onboarding

Performs CRA mentoring

Collaborates with development and maintenance of Clinical Trial Management System (CTMS)

Manages and resolves conflicting priorities to deliver on commitments

Performs additional duties as assigned

Qualification

Clinical Trial ManagementICH GCP ComplianceRegulatory KnowledgeCertified MonitorClinical Research KnowledgeMonitoring Activities ManagementCustomer Service OrientationManage StressMulti-taskLocal Language ProficiencyComputer SkillsCommunication SkillsOrganizational SkillsProblem-Solving SkillsTeam CollaborationAttention to DetailNegotiation SkillsLeadership Skills