Lead Clinical Research Associate

If you are a current Jazz employee please apply via the Internal Career site

The Lead Clinical Research Associate (Lead CRA) independently manages clinical monitoring activities for a portfolio of investigator sites within one or more Jazz-sponsored clinical trials, while also acting as a subject matter expert and point of escalation for site-level issues. The Lead CRA provides in-field mentorship and quality oversight to CRAs (internal and CRO-partnered), helps translate centralized and risk-based monitoring signals into site-level action, and partners closely with the Global Study Manager and Central Monitoring team to ensure studies are conducted in compliance with the protocol, ICH-GCP, and applicable regulations. 

Essential Functions/Responsibilities

·         Independently perform and oversee the full range of on-site and remote monitoring visits (qualification, site initiation, interim/routine, close-out, and oversight, and for-cause) in accordance with the monitoring plan, SOPs, and ICH-GCP. 

·         Serve as the primary point of contact and escalation path for a defined group of clinical research associates assigned to one or more Jazz-sponsored clinical trials, proactively identifying and resolving site performance, compliance, and data quality issues. 

·         Partner with the Central Monitoring and Trial Risk Management functions to interpret key risk indicators (KRIs) and centralized analytics, and translate those signals into targeted, risk-based actions at the site level (e.g., adjusted visit frequency, targeted source data verification, focused CRA follow-up). 

·         Provide day-to-day guidance, mentorship, and in-field co-monitoring/training to internal CRAs and FSP staff, supporting their onboarding and ongoing development. 

·         Provide oversight and in-field co-monitoring and/or oversight monitoring visits of CRO-partnered staff for outsourced clinical trials and monitor overall KPIs to evaluate performance of vendors. 

·         Review and approve monitoring visit reports and follow-up letters for assigned CRAs prior to finalization; ensure timely, accurate, and audit-ready documentation. 

·         Support site start-up activities, including regulatory document collection, site contract and budget review, and site readiness assessments by collecting, filing and reconciling documents at qualification visits and site initiation visits. 

·         Ensure timely resolution of data queries, protocol deviations, and action items in partnership with sites, Data Management, and Biostatistics. 

·         Maintain oversight of the Trial Master File (TMF) for assigned sites, ensuring inspection readiness and adherence to filing timelines. 

·         Lead the development and continuous improvement of monitoring plans, site management strategies, and study-specific tools and training materials. 

·         Support recruitment and retention strategy by monitoring enrollment trends and working with sites and the study team to address barriers. 

·         Participate in the evaluation and oversight of vendor and CRO monitoring performance, including co-monitoring visits and quality checks. 

·         Support internal audits and regulatory inspections as a subject matter expert for assigned sites and studies. 

·         Escalate significant risks, quality issues, and site performance trends to the Global Study Manager, Central Monitoring, and Trial Risk Management functions in a timely manner. 

Required Knowledge, Skills, and Abilities

·         6+ years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry, including demonstrated experience mentoring or providing lead direction and oversight of other CRAs.  Lesser experience is considered for exceptional candidates. 

·         Thorough working knowledge of ICH-GCP, applicable global regulations, and risk-based quality management (RBQM) principles, with the ability to apply them independently and judgment across varied site situations. 

·         Experience with risk-based monitoring approaches, including use of centralized analytics, key risk indicators (KRIs), and quality tolerance limits (QTLs) to inform site-level monitoring decisions. 

·         Proficiency with CTMS, eTMF, EDC, and remote monitoring/collaboration platforms. 

·         Therapeutic area experience in oncology and/or neuroscience strongly preferred. 

·         Strong written and verbal communication skills, with the ability to communicate effectively with investigator sites, cross-functional study teams, and senior stakeholders. 

·         Excellent organizational skills and demonstrated ability to manage competing priorities across multiple sites and studies. 

·         Sound judgment and problem-solving ability, with a track record of identifying issues early and driving them to resolution. 

·         Previous experience managing people and/or teams. 

·         Ability to travel approximately 40-60%, including overnight and occasional international travel, and to maintain a valid driver's license and/or passport as required. 

Required/Preferred Education and Licenses

·         Bachelor's degree in a life science, nursing, or related discipline required; RN or advanced degree a plus. 

·         Valid driver's license and/or passport required, consistent with travel expectations of the role. 

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