Site Care Partner

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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

• Qualify and activate assigned clinical trial sites • Support country and site selection, including site list review, protocol feasibility, and country outreach surveys • Conduct site start-up activities, including site qualification, activation checklists, informed consent finalization, and Site Initiation Visits • Coordinate training and documentation required for site activation • Complete post-qualification and post-SIV follow-up to ensure site readiness for First Subject First Visit • Partner with Clinical Research Associates to ensure monitoring readiness and enrollment delivery • Build and maintain relationships with investigator sites, site organizations, and strategic partners • Coordinate resolution of escalated site delivery issues, including vendor, contracts, and payment issues • Manage investigational product and ancillary supply strategies throughout the study lifecycle • Partner with regulatory authorities and study start-up teams to complete country and local registry activities • Provide site recommendations and intelligence on country, regional, site, process, and performance metrics • Support import/export requirements for investigational products and ancillary supplies • Review site reports and related issues and support quality and consistency of monitoring • Support positive investigator relationships and escalate training or compliance concerns • Comply with Parexel training, timesheet, expense-reporting, CV-update, process, ICH-GCP, and applicable regulatory requirements

🎯 Requirements

• Must have oncology study experience • Experience in another therapeutic area is a plus • Knowledge of Good Clinical Practice, ICH Guidelines, and applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Good communication, presentation, and interpersonal skills • Ability to manage required travel • Networking and relationship-building skills • Ability to manage cross-functional relationships • Ability to communicate effectively with internal and external stakeholders • Ability to adapt to changing technologies and processes • Knowledge of country-specific GCP requirements • Ability to overcome barriers during implementation of new processes and systems • Ability to build effective relationships with investigator site staff and stakeholders • Ability to manage escalated site issues while meeting client and site staff needs • Demonstrated site management experience with prior experience as a CRA • Demonstrated experience in site start-up through site activation • Demonstrated experience in study conduct and close-out activities • Demonstrated knowledge of quality and regulatory requirements in applicable countries • Bachelor's degree or RN in a related field, or equivalent combination of education, training, and experience • At least 5 years of experience if using the equivalent combination pathway • English is required • Proficiency in the local language is preferred