Site Care Partner – Lead CRA

🔥 12 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🪙 Affiliate Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 the study lifecycle • Qualify and activate assigned sites and deploy client site strategies • Support country and site selection, 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 checklist coordination, ICF finalization, and SIV as applicable • Coordinate training and documentation required for site activation • Ensure post-qualification and post-SIV follow-up for site readiness • Partner with CRAs to ensure 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 issues, including vendor, contract, and payment issues • Manage investigational product and ancillary supply strategies throughout the study • Plan and deliver site recruitment in line with global, country, and local targets • Partner with regulatory authorities and study start-up teams on country/local registries • Provide site recommendations and local intelligence based on site performance metrics • Support study management with investigational product import/export requirements • 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-GCP, 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 • 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 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 • Effective verbal and written communication skills • Ability to manage escalated site issues • Demonstrated experience in site management with prior experience as a CRA • Demonstrated experience in start-up activities 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’ experience estimated for the equivalent combination pathway • English is required • Proficiency in local language preferred

🏖️ Benefits

• Equal opportunity employment • Required training curriculum • Travel reimbursement through expense reports (implied by required expense reporting)