
1001 - 5000 employees
đĽ Healthcare
đź Consulting
đŚ 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.
đĽ 0 minutes ago
đ Argentina, Mexico, +2 more countries â Remote
â° Full Time
đ˘ Junior
đ§Ş Clinical Research
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1001 - 5000 employees
đĽ Healthcare
đź Consulting
đŚ 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.
⢠Lead delivery of clinical study site management activities by coordinating Clinical staff within a geographic region ⢠Ensure site qualification, initiation, interim monitoring, site management, and study close-out activities comply with protocols, study plans, and Worldwide SOPs ⢠Ensure quality and timeliness of clinical deliverables for assigned programs and/or region ⢠Collaborate with Project Management to set site management targets and monitoring strategy ⢠Provide leadership and direction to clinical site management team members from study start through closure ⢠Serve as primary Site Management point of contact for monitoring and site activities ⢠Manage monitoring deliverables against study budget and identify out-of-scope activities ⢠Customize study-specific Site Management quality documents, including Clinical Monitoring Plans ⢠Oversee CMP compliance, site visits, trip reports, and visit follow-up letters ⢠Review protocol deviations and visit action items ⢠Train CRAs on clinical aspects of studies ⢠Develop and implement patient recruitment strategies and track enrollment ⢠Improve site data quality and ensure data integrity ⢠Track and measure Site Management deliverables, trends, analytics, financial performance, metrics, and resource allocation ⢠Oversee TMF compliance and inspection readiness ⢠Formulate regional monitoring strategy and forecast site visits and staffing needs ⢠Review and finalize trip reports ⢠Perform site qualification, initiation, interim monitoring, and close-out visits as needed ⢠Resolve and escalate monitoring and site issues ⢠Identify and mitigate risks ⢠Represent Site Management as primary project contact when required ⢠Conduct co-visits to ensure site, CRA, and study-procedure quality ⢠Perform other duties as assigned
⢠Excellent interpersonal, oral and written communication skills in English ⢠Excellent planning, organizational, presentation, and time management skills ⢠Flexibility to change ⢠Ability to manage multiple and varied tasks ⢠Ability to negotiate and influence diplomatically ⢠Initiative and problem-solving skills ⢠Ability to prioritize tasks, plan proactively, and accomplish goals with minimal supervision ⢠Ability to lead and motivate a team remotely ⢠Ability to contribute to monitoring and site management process initiatives ⢠Strong customer focus and professional sponsor interaction ⢠Extensive understanding of clinical research principles and processes ⢠Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements ⢠Experience in the study therapeutic indication/area ⢠Thorough understanding of standard operating procedures ⢠Proficient knowledge of Microsoft Office, eCRF, and IVRS packages ⢠Proficiency with IxRS, CTMS, and EDC systems ⢠Four-year college curriculum or equivalent with a major concentration in biological, physical, or health studies and a minimum of three years as a Senior Clinical Research Associate (or equivalent) ⢠OR two-year college curriculum or equivalent education/training and a minimum of five years as a Senior Clinical Research Associate; nursing degree or equivalent life science degree preferred ⢠OR minimum six-month experience functioning as CTM/LCRA (or equivalent), supporting the main CTM and coordinating clinical operations activities ⢠Valid current passport required ⢠Driving license required
⢠Diverse and inclusive work environment ⢠Supportive, team-oriented atmosphere ⢠Hands-on, accessible leadership ⢠Equal employment opportunities ⢠Travel required
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đŚđˇ Argentina â Remote
đ° $5M Series A - Indeed on 2005-07
â° Full Time
đ˘ Junior
đĄ Mid-level
đ§Ş Clinical Research
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