Lead Clinical Research Associate

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

Job Description Summary

The Lead CRA is an important member of the Alira Health Clinical team. The Lead CRA provides oversight, leadership, and guidance in the management and execution of clinical trial monitoring to ensure compliance and quality. Lead CRAs work closely with the Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Job Description

THE LEAD CLINICAL RESEARCH ASSOCIATE ROLE

ESSENTIAL JOB FUNCTIONS*

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

• May perform Central Monitoring activities, or act as the primary liaison between site and Central Monitor.

• Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct.

• Exhibits meticulous care in upholding the privacy of all subjects/participants.

• Escalates quality issues or trends appropriately per the escalation pathway.

• Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols. Confirms IP has been dispensed and administered to participants in compliance with the study protocol. Leverages expertise in GCP, local regulations and Alira Health procedures to ensure IP is properly labeled, relabeled, transported, released, returned or destroyed.

• Reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness. Reconciles the ISF with the Trial Master File (TMF), ensuring filing of essential documents in accordance with local guidelines and regulations.

• Performs quality checks on regulatory documents per ALCOA+ principles, collecting copies for TMF filing. Supports audit readiness by submitting documents to the TMF, utilizing the filing index and medidata as necessary.

• Verification and review of safety events (AE/SAE/UADE/AESI, etc) including reconciliation of concomitant medications and medical history to confirm accurate reporting in accordance with the protocol, local regulations and regulations.

• Prepares accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and the Clinical Monitoring Plan timelines. Reports detail site-specific concerns, follow-up tasks, corrective actions, protocol deviations and violations, enrollment progress and safety events collected. 

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

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

• Assists in set up/collection of site-specific ethics documents and site contract negotiation.

• Provides monthly billing information to finance team as required.

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

• Provides monthly billing information to the finance and project management team, as needed.

• Performs CRA training and mentoring to more junior level CRAs.

• May co-monitor and perform Evaluation Visits for more junior level CRAs.

• Provides guidance, oversight, and feedback to the study team to ensure adherence to project scope, study plans, timelines, and budget requirements.

• Oversees Clinical Research Associates (CRAs) to ensure monitoring visits are conducted within the timelines specific in the Clinical Monitoring Plan or adjusted as necessary to align with the project requirements. Monitors site and CRA performance to maintain SDV rates within study goal range, directing CRAs to perform additional visits when thresholds are not met.

• Oversees CRAs in the execution of ongoing site management activities, including reviewing Electronic Data Capture (EDC) queries, resolving follow-up items and responding to site staff inquiries in a timely manner.

• Can serve as a line manager with direct reports, with accountability for CRA