Site Care Partner – Short-Term Assignment

🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🪙 Affiliate Manager

🦅 H1B Visa Sponsor

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Logo of Parexel

Parexel

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

• Serve as the client’s primary point of contact for investigative sites • Provide site support and engagement throughout the study lifecycle • Contribute to country and site selection using local intelligence • Qualify and activate assigned sites and conduct site start-up activities • Coordinate site activation checklist items, informed consent finalization, and Site Initiation Visits • Ensure site initiation training, documentation, and systems are completed • Follow up after assessments and initiation visits to ensure site readiness • Build investigator-site relationships and provide operational oversight • Coordinate communications and resolution of escalated site issues • Manage investigational product and ancillary supply strategies • Plan and support site recruitment, enrollment, and delivery against study targets • Maintain regular communication with investigator sites regarding recruitment, data entry, performance, and study feedback • Coordinate with regulatory, activation, monitoring, clinical, contracts, and study management functions • Act as operational contact for site-level questions and resolve issues • Review monitoring reports and support informed consent document revisions and submissions • Maintain site-level data and system management across applicable platforms • Oversee site deliverables, data currency, and site-facing deliverables • Implement risk mitigations under the study oversight plan • Support decentralized capabilities at investigator sites • Promote monitoring efficiencies, best practices, site quality, and patient safety • Complete required training, timesheets, expense reports, and CV updates • Comply with Parexel processes, ICH-GCPs, and applicable requirements

🎯 Requirements

• +5 years of experience as an experienced Senior CRA/site monitor • Demonstrated experience in site management with prior experience as a site monitor • Demonstrated experience in study start-up activities through site activation • Demonstrated experience in study conduct and closeout activities • Demonstrated knowledge of quality and regulatory requirements in applicable countries • Good computer skills and ability to embrace new technologies • Ability to communicate effectively with internal and external stakeholders • Ability to adapt to changing technologies and processes • Effective verbal and written English communication skills • Networking and relationship-building skills • Ability to manage cross-functional relationships • Bachelor’s degree or Registered Nurse in a related field, or equivalent combination of education, training and experience • English proficiency required • Ability to manage required travel of up to 75% on a regular basis

🏖️ Benefits

• Short-term 7 month assignment • Remote work in the United States • Opportunity for experienced Senior CRAs to take the next step in their career

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