Site Care Partner – Lead CRA

🕒 September 24

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🪙 Affiliate Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 25%

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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

• Serve as a crucial liaison for investigative sites throughout a study's lifecycle • Qualify and activate assigned sites and deploy client site strategies • Support country and site selection activities, including site list review and site qualification • Provide country/regional input on protocol feasibility, standard of care, and medical practices • Conduct site start-up activities, including site qualification, activation checklists, ICF finalization, and SIV as applicable • Coordinate site initiation training and complete documentation and systems required for activation • Ensure follow-up completion after site qualification visits and SIV to prepare sites for FSFV • Partner with CRAs to ensure site monitoring readiness and enrollment delivery • Build and maintain relationships with site organizations, strategic partners, investigators, and site staff • Coordinate communications and resolution of escalated site issues, including vendor, contract, and payment issues • Manage investigational product and ancillary supply strategies and country requirements • Support recruitment planning and delivery consistent with global, country, and local targets • Partner with regulatory authorities and study start-up teams to complete country/local registries • Provide site recommendations and local intelligence based on country, site, process, and performance knowledge • Support study management with local import/export requirements for investigational products and supplies • Review site reports and related issues • Assure quality and consistency in monitoring delivery • Support CRA-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) • English is required; proficiency in local language preferred

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