Senior Clinical Research Associate – FSP

🔥 13 hours ago

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.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.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Conduct and provide support for in-house and outsourced clinical site monitoring activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols • Collaborate with study teams during start-up/feasibility and conduct site identification and assessment tasks • Identify root causes and proactively escalate and resolve CRA and site performance issues through collaboration with stakeholders • Provide monitoring expertise, mentoring, and training to less experienced team members as required • Build positive working relationships and proactively seek feedback from site teams, including Principal Investigators, Study Coordinators, Pharmacists, and Site Administration • Partner with study teams and sites on site outreach activities, including patient recruitment and retention strategies • Provide input and lead cross-functional teams in determining monitoring strategy, including risk-based monitoring • Use regional knowledge to localize study processes and documents where possible • Represent Monitoring at Investigator Meetings as required • Collaborate with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions aligned with project goals and operational efficiency • Perform other tasks as required

🎯 Requirements

• Ability to travel domestically • Demonstrates ability to work independently and in a team environment • Proficiency with MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint) • Excellent oral and written communication skills and strong organizational abilities • Relevant clinical research experience in biotechnology, pharmaceutical, Contract Research Organization (CRO), or medical device settings • Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations • Experience in Oncology preferred • 5+ years of relevant monitoring experience • BA/BS, nursing degree, or advanced degree • Degree in the life sciences preferred