Site Care Partner

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 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 a crucial liaison for investigative sites throughout the study lifecycle • Qualify and activate assigned sites and deploy client site strategies • Support country and site selection, feasibility strategy, analytics, and protocol feasibility activities • Provide country/regional input to strategy, feasibility, protocol design, and outreach surveys • Conduct site start-up activities, including site qualification, activation checklist coordination, ICF finalization, and SIVs as applicable • Manage issues that may compromise time to site activation and ensure site readiness for FSFV • Partner with CRAs to ensure monitoring readiness and enrollment delivery • Build and maintain investigator site, site organization, and strategic partner relationships • Coordinate resolution of escalated site issues, including vendor, contract, and payment issues • Manage investigational product and ancillary supply strategies throughout the study lifecycle • Partner with regulatory authorities and study start-up teams on country/local registry completion • Gather country/region intelligence and provide site recommendations and site performance insights • Support import/export requirement definition for investigational products and ancillary supplies • Review site reports and related issues during study conduct • Review and update SMO assessments and continuity/contingency plans • Support decentralized capabilities, issue resolution, and client pipeline opportunities at investigator sites • Act as a subject matter expert on client systems and processes when needed • Develop efficiencies and best practices to improve site performance and investigator/site satisfaction • Maintain clear communication with study teams and support CRA-investigator relationships • Complete required training, timesheets, expense reports, CV updates, and comply with Parexel processes, ICH-GCPs, and applicable requirements

🎯 Requirements

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Excellent 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 • Experience overcoming barriers during implementation of new processes and systems • 5+ years of prior experience as a CRA in a clinical research or pharma organization • Experience reviewing monitoring reports • Experience in start-up activities through site activation • Experience in conduct and close-out activities • 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’ experience when qualifying through equivalent education, training and experience • English is required • Proficiency in local language preferred • Oncology monitoring/CRA experience preferred

🏖️ Benefits

• Equal opportunity employer • Required training curriculum • Expense reimbursement through required expense reports

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