Lead Clinical Research Associate

Jazz Pharmaceuticals • Palo Alto, CA

11d • $121,600 - $182,400 • Remote

About The Position

The Lead Clinical Research Associate independently manages clinical monitoring activities for a portfolio of investigator sites across one or more Jazz-sponsored clinical trials. The role also serves as a subject matter expert and escalation point for site-level issues, provides in-field mentorship and quality oversight to internal and CRO-partnered CRAs, and translates centralized and risk-based monitoring signals into site-level actions. The Lead CRA partners closely with the Global Study Manager and Central Monitoring team to help ensure studies comply with the protocol, ICH-GCP, and applicable regulations.

The position includes oversight of site monitoring, CRA development and performance, site start-up, data quality, Trial Master File documentation, recruitment and retention, vendor monitoring, and support for audits and regulatory inspections. Travel is approximately 40–60%, including overnight and occasional international travel. The role is designated remote in the posting. For US-based candidates, the stated base pay range is $121,600 to $182,400, with possible discretionary cash bonus or incentive compensation and equity grants. Benefits include medical, dental and vision insurance, a 401(k) retirement savings plan, and flexible paid vacation.

Requirements

• At least 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 may be considered for exceptional candidates.
• Thorough working knowledge of ICH-GCP, applicable global regulations, and risk-based quality management principles, with the ability to apply them independently across varied site situations.
• Experience with risk-based monitoring approaches, including 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 or collaboration platforms.
• Strong written and verbal communication skills, including 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 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.
• Valid driver's license and/or passport, consistent with travel expectations.
• Bachelor's degree in a life science, nursing, or related discipline.

Nice To Haves

• Therapeutic area experience in oncology and/or neuroscience is strongly preferred.
• RN or advanced degree is a plus.

Responsibilities

• Independently perform and oversee on-site and remote qualification, site initiation, interim/routine, close-out, oversight, and for-cause monitoring visits in accordance with the monitoring plan, SOPs, and ICH-GCP.
• Serve as the primary contact and escalation path for assigned CRAs, identifying and resolving site performance, compliance, and data quality issues.
• Partner with Central Monitoring and Trial Risk Management to interpret key risk indicators and centralized analytics and translate them into targeted site-level monitoring actions.
• Provide day-to-day guidance, mentorship, in-field co-monitoring, and training to internal CRAs and FSP staff, supporting onboarding and ongoing development.
• Provide oversight and in-field co-monitoring or oversight monitoring of CRO-partnered staff and monitor vendor performance KPIs.
• Review and approve monitoring visit reports and follow-up letters for assigned CRAs, ensuring timely, accurate, audit-ready documentation.
• Support site start-up, including regulatory document collection, site contract and budget review, and site readiness assessments; collect, file, and reconcile documents at qualification and site initiation visits.
• Ensure timely resolution of data queries, protocol deviations, and action items with sites, Data Management, and Biostatistics.
• Maintain oversight of the TMF for assigned sites, ensuring inspection readiness and adherence to filing timelines.
• Lead development and continuous improvement of monitoring plans, site management strategies, 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 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.
• Promptly escalate significant risks, quality issues, and site performance trends to the Global Study Manager, Central Monitoring, and Trial Risk Management functions.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement savings plan
• Flexible paid vacation
• May be eligible for discretionary annual cash bonus or incentive compensation, depending on the role
• May receive discretionary equity grants

What This Job Offers

• Job Type: Full-time
• Career Level: Senior