Lead Clinical Research Associate

📋 Description

• • Lead site monitoring activities including selection, initiation, monitoring, and close-out visits in full compliance with ICH GCP, Alira Health SOPs, and regulatory requirements.
• • Perform central monitoring activities or serve as the primary liaison between investigative sites and central monitors to ensure data quality and protocol adherence.
• • Oversee and mentor junior Clinical Research Associates (CRAs), providing guidance on monitoring best practices, protocol interpretation, and site management.
• • Conduct thorough reviews of Investigator Site Files (ISF) to ensure audit readiness, accuracy, completeness, and alignment with Trial Master File (TMF) requirements under ALCOA+ principles.
• • Verify and reconcile safety events (AE/SAE/UADE/AESI), concomitant medications, and medical histories to ensure accurate and compliant reporting per protocol and regulatory standards.
• • Manage investigational product (IP) inventory, accountability, storage conditions, labeling, transport, return, and destruction in accordance with GCP and study-specific protocols.
• • Perform quality checks on regulatory documents and ensure timely submission to the TMF using appropriate systems such as Medidata and filing indexes.
• • Prepare detailed monitoring visit reports and communication logs within Alira Health SOP and Clinical Monitoring Plan timelines, documenting protocol deviations, corrective actions, enrollment progress, and safety concerns.
• • Monitor CRA performance through review of monitoring reports and metric tracking (e.g., EDC query resolution times, follow-up item durations) to ensure SDV rates meet study targets.
• • Direct CRAs to conduct additional site visits when performance thresholds are not met and provide feedback to improve site management and compliance.
• • Oversee ongoing site management activities including timely resolution of EDC queries, response to site staff inquiries, and tracking of recruitment metrics aligned with project goals.
• • Serve as a line manager for CRAs, conducting annual performance reviews, defining KPIs, assigning studies/sites, and supporting career progression.
• • Participate in internal, client, scientific, and bid defense meetings; prepare and present at Investigator Meetings and project-specific CRA training sessions.
• • Collaborate with Project Managers, Data Management, and Finance teams to resolve CRF queries, ensure accurate billing, and support budget management for stand-alone projects.
• • Contribute to resourcing planning for upcoming and ongoing clinical trials and assist in the hiring, onboarding, and training of new CRAs.
• • Review CRA timesheet submissions for accuracy and compliance with internal policies.
• • Support audits by preparing site documentation, attending audit meetings, and ensuring audit readiness across assigned studies.
• • Maintain up-to-date knowledge of ICH GCP, ISO 14155, and local regulatory requirements to ensure all activities remain compliant.
• • Travel up to 85% to conduct on-site monitoring visits, attend investigator meetings, and support clinical operations across global locations.
• • Foster a collaborative, inclusive team environment that upholds Alira Health’s core values: be courageous, be accountable, be honest, be inclusive, and elevate others.
• • Work closely with cross-functional teams to ensure seamless clinical trial execution, from site activation through close-out, aligning with project scope, timelines, and budget expectations.