Senior Clinical Research Associate (US-West) - FSP

Key Accountabilities

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• Serve as the primary point of contact for assigned investigator sites and work in partnership with the SCP to ensure quality of site delivery
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
• Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
• Attend investigator meeting when required (virtual or F2F) and provide enrollment support
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit
• Submit all required reports, documentation, updates and tracking within required timeframes
• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions
• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities
• Ensures adequate oversight of the investigational product at the investigator site
• Support database release as needed
• May undertake the responsibilities of an unblinded monitor where appropriate

Clinical/Scientific and Site Monitoring Risk

• Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
• Interact with investigator site health care professionals in a manner which enhances the client’s credibility, scientific leadership and in order to facilitate the client’s clinical development goals
• Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
• Drive Quality Event (QE) remediation, when applicable
• Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable

Collaboration

• Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)
• Partners with SCP and Country Study Operations Manager (SOM) when required
• Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)
• May act as a Mentor for Clinical Research Associates

Compliance with Parexel standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates curriculum vitae (CV) as required
• Maintains a working knowledge of and complies with Parexel processes, International Conference on Harmonization (ICH) - GCPs, and other applicable requirements