Lead CRA – Site Care Partner

🔥 0 minutes ago

🇺🇸 United States – 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

• Provide necessary support and engagement to investigative sites throughout the study lifecycle • Resolve site issues and uphold the client’s reputation • Serve as the main client point of contact for investigative sites • Manage site start-up activities through activation, including PTA, activation checklists, ICD finalization, and SIV • Support country and site selection activities and provide local intelligence • Ensure site initiation activities, training, documentation, and systems are completed • Ensure site readiness for First Subject First Visit and monitoring readiness • Build and retain investigator site relationships • Coordinate resolution of escalated site delivery issues, including vendor, contract, and payment issues • Plan and support site recruitment and enrollment delivery • Maintain regular communications with investigator sites regarding recruitment, data entry, performance metrics, and study feedback • Coordinate with regulatory and site activation stakeholders • Act as operational point of contact for site-level questions and escalate as needed • Review site monitoring reports and support ICD revisions and submissions • Maintain site-level system management across EDC, Shared Investigator Platform, Site Profile, and other systems • Review SMO Assessments and maintain continuity and contingency plans • Manage site practices differing from client practices • Oversee site deliverables against study targets, including data cuts, sweeps, interim analyses, and database locks • Coordinate with study monitors, contracts, site activation, clinical, and other functions • Use analytic tools and country intelligence to identify quality and compliance risks and implement mitigation plans

🎯 Requirements

• 5+ years of experience as a site monitor, specifically Oncology monitoring • Demonstrated experience in start up activities through to site activation • Demonstrated experience in conduct and close out activities • Demonstrated knowledge of quality and regulatory requirements in applicable countries • Good computer skills and ability to embrace new technologies • Ability to communicate effectively and appropriately with internal and external stakeholders • Ability to adapt to changing technologies and processes • Effective verbal and written communication skills • Ability to overcome barriers during implementation of new processes and systems • Networking and relationship building skills • Ability to manage cross-functional relationships • Ability to build effective relationships with investigator site staff and other stakeholders • Ability to manage required travel of up to 75% on a regular basis • Bachelor's Degree or Registered Nurse