Site Care Partner, Lead CRA

🕒 March 27

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🪙 Affiliate Manager

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• The Site Care Partner is a crucial liaison for investigative sites throughout a study's lifecycle, responsible for site start-up, activation, relationship management, recruitment, and quality assurance. • Conducts study start-up activities at the site level including Site Qualification, coordination of site activation checklist items, Informed Consent Form (ICF) finalization, Site Initiation Visit (SIV) as applicable, including management of issues that may compromise time to site activation • Responsible for relationship building and operational quality of the site. • Partners with Clinical Research Associate (CRA) to ensure site monitoring readiness in anticipation of FSFV. • Accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Jointly responsible with CRA for enrollment delivery during study conduct. • Provides input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience) • Demonstrated experience in site management with prior experience as a CRA in Oncology • Demonstrated experience in start-up activities through site activation • Demonstrated experience in conduct and close out activities • Demonstrated knowledge of quality and regulatory requirements in applicable countries • Proficiency in local language preferred. English is required

🏖️ Benefits

• N/A