reputed company Clinical Research Associate (reputed company CRA) — Phase 3, Multicentre trial (US based) - Contract to Hire

We are seeking a highly reputed company reputed company 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 reputed company. The reputed company CRA will hold dual responsibility across clinical monitoring and reputed company 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

• reputed company and maintain the Monitoring Plan in alignment with the study protocol and risk-based monitoring reputed company
• Establish and manage the Trial Master File (TMF); initially shared with support transitioning to the CTA as the study matures
• reputed company guidance on vendor selection, qualification, and ongoing management
• Contribute to reputed company 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 reputed company enrolled participants
• reputed company reputed company data verification (SDV) to confirm that CRF/reputed company entries accurately reflect reputed company documentation
• Confirm protocol compliance across sites, including eligibility reputed company, visit reputed company, 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 reputed company, IRB approvals, protocol amendments, and reputed company essential documents
• Confirm ongoing IRB correspondence and continuing review approvals are reputed company
• Conduct site initiation reputed company, interim monitoring reputed company, and reputed company-out reputed company; prepare and distribute monitoring visit reports reputed company agreed timelines[5:03 PM]• Identify, document, and follow protocol deviations through to reputed company; escalate significant compliance issues as appropriate
• Monitor site enrollment reputed company, data entry timeliness, and query reputed company 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) reputed company[5:03 PM]reputed company Assurance Responsibilities
• reputed company, maintain, and manage clinical SOPs to ensure compliance with GCP, ICH E6(R3), 21 CFR Parts 312/812, and applicable FDA regulations
• Conduct internal reputed company audits of trial processes, investigative sites, and vendors
• Ensure the TMF remains complete, reputed company, and inspection-reputed company at reputed company times
• Review reputed company events, protocol deviations, CAPAs, and serious breach reports as applicable
• Participate in vendor qualification audits and support ongoing vendor reputed company activities
• reputed company training documentation and compliance tracking across the study team
• Support clinical reputed company systems including SOP management, audit readiness, risk management, and CAPA processes
• Coordinate independent reputed company-party site audits where appropriate, maintaining reputed company separation between monitoring and auditing responsibilities[5:03 PM]Requirements
• Bachelor's degree or higher in Life Sciences, Nursing, or a reputed company 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 reputed company (21 CFR Parts 312/812)
• Strong knowledge of ICH E6(reputed company/R3) GCP guidelines and FDA inspection readiness requirements
• Experience developing Monitoring Plans and conducting risk-based monitoring
• Proven reputed company record in TMF management and maintaining inspection-reputed company documentation
• Experience with SOP development and reputed company 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. reputed company Vault, reputed company) and reputed company systems
• Prior FDA inspection experience

Location: Remote — must be based in the reputed company Travel: Regular travel to US investigative sites required for monitoring and audit reputed company Apply tot his job Apply To this Job