Senior Clinical Research Associate

🔥 26 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🧪 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

• Perform feasibility studies for potential sites • Conduct pre-study, study initiation, interim monitoring, site management, and study close-out visits • Function as Lead CRA for global studies and coordinate CRAs • Develop Clinical Monitoring Plans • Review site visit trip reports and provide feedback and edits • Mentor and guide less experienced CRAs and site staff • Design study-specific tools and templates • Participate in study team, investigator, and bid defense meetings • Create and conduct training for study team members or colleagues • Work with Project Management to evaluate deliverables and study milestones • Compile regulatory and ethical submission documentation • Coordinate shipment and receipt of study materials • Document site visit findings in written reports • Provide input into protocol and CRF design • Assess, monitor, and train site staff on protocol adherence • Review subject safety information and informed consent • Conduct source document verification • Review paper or electronic CRFs and assist with data query resolution • Assist sites with Investigator Site File maintenance • Maintain regular communication with sites • Update site-related documentation for filing in the Trial Master File • Ensure site compliance with investigational product receipt, accountability, return, or destruction • Conduct accompanied site visits for CRA assessment or training • Complete final site close-out visits and reports • Ensure quality and timely submission of site data, including safety event reporting and follow-up

🎯 Requirements

• Medical Doctor (MD) degree or Pharmacist degree (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) and a minimum of three years as a Clinical Research Associate • Four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science and a minimum of five years as a Clinical Research Associate • Two-year college curriculum or equivalent education/training and a minimum of seven years as a Clinical Research Associate • Willingness to travel • Valid current passport • Driving license • Fluent in the local languages of the countries under responsibilities • Proficient in spoken and written English • Extensive understanding of clinical research principles and processes • Thorough understanding of FDA and/or EU Directives and regulations, ICH Guidelines, and local regulatory requirements • Thorough understanding of two to three therapeutic areas • Thorough understanding of standard operating procedures • Proficiency in Microsoft Office • Proficiency with IxRS and EDC systems • Excellent oral and written communication, planning, organizational, interpersonal, initiative, problem-solving, leadership, and time-management skills

🏖️ Benefits

• Diverse and inclusive work environment • Cohesive and supportive teams • Accessible, hands-on leaders • Equal employment opportunities • Employee experiences focused on appreciation, inclusion, creativity, innovation, and success