Lead Clinical Research Associate

Job not on LinkedIn

🔥 8 minutes ago

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $121.6k - $182.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Independently manage and oversee on-site and remote monitoring visits, including qualification, site initiation, interim/routine, close-out, oversight, and for-cause visits • Serve as primary point of contact and escalation path for assigned CRAs across Jazz-sponsored clinical trials • Identify and resolve site performance, compliance, and data quality issues • Translate centralized analytics, KRIs, and risk signals into targeted risk-based site actions • Provide guidance, mentorship, in-field co-monitoring, and training to internal CRAs and FSP staff • Oversee CRO-partnered staff and monitor vendor KPIs and performance • Review and approve monitoring visit reports and follow-up letters • Support site start-up, regulatory document collection, contract and budget review, and site readiness assessments • Ensure resolution of data queries, protocol deviations, and action items • Maintain Trial Master File oversight and inspection readiness • Lead development and improvement of monitoring plans, site management strategies, study tools, and training materials • Support recruitment and retention strategy by monitoring enrollment trends and addressing barriers • Participate in vendor and CRO monitoring performance evaluation, co-monitoring visits, and quality checks • Support internal audits and regulatory inspections as a subject matter expert • Escalate significant risks, quality issues, and site performance trends to study leadership and risk-management functions

🎯 Requirements

• 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 • Experience with risk-based monitoring approaches, centralized analytics, key risk indicators (KRIs), and quality tolerance limits (QTLs) • 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 • Excellent organizational skills and ability to manage competing priorities across multiple sites and studies • Sound judgment and problem-solving ability • 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 required, consistent with travel expectations • Bachelor's degree in a life science, nursing, or related discipline required • RN or advanced degree a plus

🏖️ Benefits

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume