Regulatory & Site Activation Specialist

🔥 0 minutes ago

🌐 Argentina, Brazil – Remote

🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 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

Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Serve as subject matter expert and local point of contact for regulatory submissions, site activation, and maintenance • Support end-to-end site start-up from site identification through site activation and maintenance • Act as primary country-level contact for regulatory and site activation activities in assigned studies • Customize country-specific patient information sheets, informed consent forms, labels, and local regulatory documents • Review and advise on country timelines • Communicate submission status and action plans to the Regulatory Affairs Manager and project team • Collect, receive, and perform initial review of study-specific site regulatory and essential documents • Track regulatory documents by site and/or country and follow up as needed • Identify country/site risks and generate mitigation strategies • Advise on appropriate country regulatory strategies • Maintain communication with sites to ensure timely completion of start-up and maintenance activities • Provide updates on changing regulatory requirements and support interpretation of new regulations • Maintain the regulatory intelligence database for the assigned country • Comply with SOPs, ICH GCP, and applicable regulations • Perform local quality control of submission dossiers when required • Serve as translation-review contact for submission documents when needed • Perform other assigned duties

🎯 Requirements

• Minimum 2-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or another related science • Minimum 2 years of experience in clinical research, preferably in site activation and/or regulatory-related function • Preferred minimum of one year of previous experience within the pharmaceutical/CRO industry • Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations • Fluent in local language; working knowledge of English • Strong organizational, planning, strategizing, management, monitoring, scheduling, and critiquing skills • Excellent written and verbal communication skills • Proactive issue identification and solution anticipation • Understanding of country-level cultural norms and local healthcare systems • Ability to develop relationships with local investigators and key site personnel • Ability to prioritize and adapt between detailed and strategic activities while maintaining timelines and quality • Team-oriented work style • Strong interpersonal skills in a fast-paced, deadline-oriented, changing environment • Ability to handle multiple tasks in a fast-paced and changing environment • Proficiency in Microsoft Word, Excel, and PowerPoint • Aptitude for contemporary digital systems is helpful

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible leadership • Equal employment opportunities • Employee experiences focused on respect and inclusion