Regulatory and Site Activation Specialist

🔥 1 minute ago

🇲🇽 Mexico – 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

• Support regulatory submissions, site activation, and maintenance for awarded projects • Serve as the primary point of contact for sites throughout site start-up, from site identification to activation and maintenance • Act as the country-level internal point of contact for regulatory and site activation activities • 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 reviews of study-specific site regulatory and essential documents • Track regulatory documents by site and country and follow up with sites and internal team members • Identify country- and site-level 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 • Provide local quality control of submission dossiers when required • Support translation review of 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 other 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 • Proficiency in Microsoft Word, Excel, and PowerPoint • Strong organizational, planning, management, monitoring, scheduling, and critiquing skills • Excellent written and verbal communication skills • Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment • Ability to handle multiple tasks • Understanding of country-level cultural norms and local healthcare systems • Ability to initiate and develop relationships with local investigators and key site personnel • Ability to prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality • Familiarity with SOPs, ICH GCP, and applicable regulations

🏖️ Benefits

• Equal employment opportunities • Diverse and inclusive work environment • Supportive and collaborative teams • Professional growth and development opportunities