Site Care Partner

🔥 20 hours ago

🦀 Maryland – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

🪙 Affiliate Manager

🦅 H1B Visa Sponsor

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👻 Ghost score 10%

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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

• Deploy client site strategies by qualifying and activating assigned sites • Support country and site selection activities, including site list assessment and qualification output • Provide country/regional input on protocol feasibility, standard of care, and medical practices • Conduct site start-up activities, including site qualification, activation checklist coordination, ICF finalization, and SIV as applicable • Manage issues that may compromise time to site activation • Complete site initiation training, documentation, and systems required for activation • Support country-specific ICF review and deployment • Complete follow-up activities after site qualification visits and SIV to ensure site readiness for FSFV • Partner with CRA to ensure site monitoring readiness and enrollment delivery • Build and maintain relationships with site organizations, strategic partners, investigators, and site staff • Coordinate communication and resolution of escalated site delivery issues • Ensure IP and ancillary supply strategies meet site and country requirements throughout the study • Plan and deliver site recruitment in line with global/country plans and local targets • Partner with regulatory authorities and study start-up teams to complete country/local registries through site activation • Provide site recommendations and local intelligence based on country, site, process, practice, and performance knowledge • Support study management with local investigational product import/export requirements • Review site reports and related issues • Assure quality and consistency in monitoring delivery • Support CRA in investigator relationships and escalate training or compliance concerns • Complete required training, timesheets, expense reports, and CV updates • Comply with Parexel processes, ICH-GCPs, and applicable requirements

🎯 Requirements

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Must demonstrate good computer skills and be able to embrace new technologies • Good communication, presentation, and interpersonal skills • Ability to manage required travel • Demonstrated networking and relationship building skills • Demonstrated ability to manage cross functional relationships • Ability to communicate effectively and appropriately with internal & external stakeholders • Ability to adapt to changing technologies and processes • Knowledge of country requirements for GCP that may be different to those of client procedures • Effectively overcoming barriers encountered during the implementation of new processes and systems • Identifies and builds effective relationships with investigator site staff and other stakeholders • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization • Able to manage issues that are escalated by site staff in a way that meets the needs of both the client and the site staff • Demonstrated experience in site management with prior experience as a CRA • 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 • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 5 years’ experience) • Proficiency in local language preferred • English is required

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