Senior Clinical Research Associate

Position Overview

• Location Type: Remote
• Employment Type: Part time
• Job Title: Senior Clinical Research Associate (CRA) - Ukraine
• Company: Alira Health
• Company Values: Be courageous, be accountable, be honest, be inclusive and elevate others.

Job Summary: Alira Health is seeking a highly motivated Senior Clinical Research Associate (CRA) to support clinical trials in Ukraine. This role requires a strong understanding of clinical trial regulations and procedures, excellent communication skills, and the ability to work independently and collaboratively within a global team. The team values collaboration, innovation, and a commitment to upholding the highest standards of quality and integrity.

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 the 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 US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers.

Requirements

• (Specific requirements details are missing from the provided text. Further information would be needed to detail specific education, experience, and skills required.)

Application Instructions

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