Clinical Research Associate II/Senior Clinical Research Associate

🔥 3 minutes ago

🤠 Texas – Remote

🤠 Texas – 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 • Conduct site initiation, routine monitoring, remote/electronic monitoring, and site close-out activities • Ensure clinical trials comply with monitoring plans, applicable laws, GCP, SOPs, and sponsor standards • Serve as primary contact for assigned investigator sites and coordinate with study teams, vendors, and Site Care Partners • Provide site personnel coaching, training, protocol training, and recruitment support • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics • Identify and resolve site issues, including corrective and preventive actions • Resolve data queries and support database release • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support patient safety, eligibility, clinical guidance, quality event remediation, audits, and CAPA activities • May undertake unblinded monitor responsibilities where appropriate

🎯 Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations • Minimum 2 years relevant experience in clinical research site monitoring • 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

🏖️ Benefits

• Equal opportunity employment • Travel reimbursement or related travel support is not explicitly stated