Clinical Research Associate (CRA)

Employment Type: Full-time

Position Overview

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. We foster an environment where all contributions and new ideas are explored with an open mind, driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.

The Clinical Research Associate (CRA) is a vital member of the Alira Health Clinical team. This role requires a highly motivated individual who functions independently to conduct site monitoring responsibilities for clinical trials. The CRA will provide oversight, leadership, and guidance in the management and execution of clinical trials, ensuring compliance and quality. You will work closely with Lead CRAs, Sr CRAs, in-house CRAs, the Associate Director of Clinical Monitoring, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Requirement: 2+ years of oncology monitoring experience is mandatory for this position.

Key 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 the development of study-specific Monitoring Plans and training presentations as required.
• Assists in the setup/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 the study budget and acts as a 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 the 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 binders 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.
• Assists in CRA new hire training and onboarding.
• Performs CRA mentoring.
• Collaborates with the development and maintenance of the Clinical Trial Management System (CTMS).
• Manages and resolves conflicting priorities to deliver on commitments.
• Performs additional duties as assigned.

Desired Qualifications & Experience

• EU: Graduation in a scientific health field.
• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15 Nov 2011.
• Ability to establish and maintain positive relationships with Sponsor.

Application Instructions

• Referral Link: If you are being referred to one of our roles by a connection in Alira Health, please apply using the referral link emailed to you.