Clinical Research Associate II/Sr. Clinical Research Associate

🔥 0 minutes ago

🏈 Ohio – Remote

🏈 Ohio – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Manage site management, site monitoring and close-out of assigned clinical trial investigator sites • Ensure patient safety and quality study execution in accordance with applicable laws, GCP and Sponsor standards • Manage investigator site relationships and assigned operational aspects from site activation through database lock • Serve as primary point of contact for assigned investigator sites • Facilitate information flow between study team members, vendors and investigator sites • Provide site development, coaching, training and protocol support • Support enrollment and recruitment initiatives • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring and closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit required reports, TMF documentation, site reports, protocol deviations, recruitment and study metrics • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release and, where appropriate, undertake unblinded monitor responsibilities • Maintain product, protocol and therapy-area knowledge and support patient safety and clinical guidance • Drive Quality Event remediation and audit observation CAPA activities when applicable

🎯 Requirements

• Minimum 2 years relevant experience in clinical research site monitoring • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Must be fluent in English and in the native language(s) of the country they will work in • Ability to travel 60-80% • Valid driver’s license and passport required • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

🏖️ Benefits

• Equal opportunity employer • Qualified applicants receive consideration for employment without regard to legally protected status