Senior Clinical Research Associate – Early Development

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Support monitoring and site management activities for client-sponsored studies • Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely • Partner with Clinical Trial Liaison and client functions to support site activation and deliverables • Establish and maintain relationships with investigator site staff • Perform drug accountability, reconciliation, and destruction • Prepare and maintain Oversight Monitoring Plan • Review study metrics and assess CRO CRA and investigator site performance • Conduct oversight monitoring visits independently or alongside CRO CRA • Review source documentation and verify accurate data capture according to ALCOA principles • Report study conduct status and follow up on issues and action items • Maintain site regulatory files and verify timely submission of study documentation, including safety reporting • Write monitoring visit reports, oversight monitoring visit reports, and study correspondence • Identify, record, track, trend, and escalate protocol deviations and study-related issues • Maintain communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs • Participate in team meetings and process improvement initiatives • Support inspection readiness activities and ensure data integrity and protocol deliverables

🎯 Requirements

• Bachelor's degree (or equivalent) • Minimum of 5 years of related experience for Snr CRA • Strong analytical problem-solving skills and critical thinking abilities • Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA) • Effective communication and interpersonal skills to build relationships internally and externally • Familiarity with medical terminology • Proficiency in Microsoft Office, EDC, CTMS, and data repositories • Demonstrated ability to deliver clear and concise written reports • Effective prioritization and time management skills

🏖️ Benefits

• Equal opportunity employer • Consideration without regard to legally protected status