Senior Clinical Research Associate

🔥 0 minutes 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

• Manage investigator site relationships and assigned clinical trial sites from activation through database lock and close-out • Conduct onsite and remote/electronic monitoring in accordance with monitoring plans, SOPs, GCP and applicable laws • Serve as primary contact for assigned investigator sites and coordinate information flow with study teams and vendors • Provide site development, coaching, protocol training and recruitment support • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment and study progress tracking • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and conduct site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release and unblinded monitoring where appropriate • Maintain product, protocol and therapy-area knowledge and support patient safety and eligibility • Drive Quality Event remediation and audit CAPA activities when applicable

🎯 Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Must be fluent in English and in the native language(s) of the country they will work in • Ability to travel 60-80% • Valid driver’s license and passport required • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent