Lead Clinical Research Associate (Lead CRA) — Phase 3, Multicentre trial (US based)

We are seeking a highly experienced Lead Clinical Research Associate to play a central role in the delivery of a Phase 3 multicentre clinical trial across US investigative sites. This is a fully remote position based in the United States. The Lead CRA will hold dual responsibility across clinical monitoring and quality assurance, working closely with the Data Manager, Clinical Trial Assistant (CTA), and vendor partners to ensure the study is executed to the highest standards of GCP, ICH E6(R3), and FDA regulatory compliance. Start-Up Responsibilities • Develop and maintain the Monitoring Plan in alignment with the study protocol and risk-based monitoring strategy • Establish and manage the Trial Master File (TMF); initially shared with support transitioning to the CTA as the study matures • Provide guidance on vendor selection, qualification, and ongoing management • Contribute to EDC platform selection in collaboration with the Data Manager[5:03 PM]Clinical Trial Monitoring Responsibilities • Verify that informed consent has been properly obtained and documented for all enrolled participants • Perform source data verification (SDV) to confirm that CRF/EDC entries accurately reflect source documentation • Confirm protocol compliance across sites, including eligibility criteria, visit windows, and required study procedures • Review and reconcile adverse event (AE) and serious adverse event (SAE) reporting for accuracy, completeness, timeliness, and appropriate documentation • Verify investigational product accountability, including shipment, storage, dispensing, and return records • Assess site personnel qualifications, training records, and delegation of authority logs • Review Investigator Site Files (ISF) and Regulatory Binders for completeness, including CVs, IRB approvals, protocol amendments, and all essential documents • Confirm ongoing IRB correspondence and continuing review approvals are current • Conduct site initiation visits, interim monitoring visits, and close-out visits; prepare and distribute monitoring visit reports within agreed timelines[5:03 PM]• Identify, document, and follow protocol deviations through to resolution; escalate significant compliance issues as appropriate • Monitor site enrollment progress, data entry timeliness, and query resolution rates • Execute centralised and remote monitoring activities in line with the Monitoring Plan; identify and escalate emerging risk signals as part of the risk-based monitoring (RBM) framework[5:03 PM]Quality Assurance Responsibilities • Develop, maintain, and manage clinical SOPs to ensure compliance with GCP, ICH E6(R3), 21 CFR Parts 312/812, and applicable FDA regulations • Conduct internal quality audits of trial processes, investigative sites, and vendors • Ensure the TMF remains complete, current, and inspection-ready at all times • Review quality events, protocol deviations, CAPAs, and serious breach reports as applicable • Participate in vendor qualification audits and support ongoing vendor oversight activities • Oversee training documentation and compliance tracking across the study team • Support clinical quality systems including SOP management, audit readiness, risk management, and CAPA processes • Coordinate independent third-party site audits where appropriate, maintaining clear separation between monitoring and auditing responsibilities[5:03 PM]Requirements • Bachelor's degree or higher in Life Sciences, Nursing, or a related field • Minimum 6 years of clinical research experience, with at least 3 years as a CRA on Phase 3 trials • Demonstrated experience on US multicentre studies under FDA oversight (21 CFR Parts 312/812) • Strong knowledge of ICH E6(R2/R3) GCP guidelines and FDA inspection readiness requirements • Experience developing Monitoring Plans and conducting risk-based monitoring • Proven track record in TMF management and maintaining inspection-ready documentation • Experience with SOP development and quality audit activities • Excellent organisational, communication, and cross-functional collaboration skills for a remote environment Preferred • ACRP (CCRA) or SOCRA (CCRP) certification • Experience in a combined monitoring and QA role • Familiarity with eTMF platforms (e.g. Veeva Vault, Mastercontrol) and EDC systems • Prior FDA inspection experience Location: Remote — must be based in the United States Travel: Regular travel to US investigative sites required for monitoring and audit visits