Clinical Research Associate II

🔥 9 minutes ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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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

• Conduct site qualification, initiation, interim monitoring, and close-out visits • Monitor study conduct, source documentation, informed consent, subject safety information, and CRFs • Assess and train site staff on protocol requirements • Address compliance and study-related issues • Ensure regulatory, ethics, and site documentation is complete, current, and maintained for the Investigator Site File and Trial Master File • Resolve data queries with sites and maintain timely data submission • Ensure appropriate safety-event reporting and follow-up • Oversee investigational product receipt, accountability, return, or destruction • Maintain regular communication with investigative sites • Document monitoring activities and findings through timely visit reports • Contribute to protocols, CRFs, monitoring plans, and feasibility activities • Support assessment and training of other CRAs through accompanied site visits • Collaborate with sites, sponsors, and global study teams • Travel to investigative sites approximately 6–10 days per month

🎯 Requirements

• MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with at least one year of experience as a Clinical Research Associate Level I; OR • Four-year degree focused on medical, biological, physical, health, pharmacy, or a related science with at least two years of clinical research experience; OR • Two-year college curriculum or equivalent education/training, preferably nursing or life sciences, with two years of experience as a Clinical Research Associate Level I • Strong knowledge of clinical research principles and processes, GCP, ICH Guidelines, applicable FDA and/or EU regulations, local regulatory requirements, and SOPs • Clinical research knowledge across three to five therapeutic areas, or in-depth knowledge of two to three therapeutic areas • Proficiency with Microsoft Office, IxRS, and electronic data capture (EDC) systems • Excellent communication, organisation, time-management, interpersonal, initiative, and problem-solving skills • Ability to work independently in an organised and methodical way • Proficiency in spoken and written English • Fluency in the local languages of the countries under responsibility • Valid current passport and driving licence • Willingness to travel as required • Experience in full-service monitoring PREFERRED

🏖️ Benefits

• Collaborative and inclusive environment • Growth and career development opportunities • Opportunity to learn, grow, and shape the future of clinical research • Home-based remote work arrangement • Regional travel opportunities • Global collaboration with sites, sponsors, and study teams