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Moving Medicine Forward
Clinical Research Associate
Location
Argentina
Posted
23 days ago
Salary
0
Seniority
Mid Level
Job Description
Clinical Research Associate
CTI Clinical Trial and Consulting Services
• Serve as main CTI contact for assigned study sites • Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP • Assist with study start-up activities, including feasibility, pre-study activities and site selection • Collect, review and track essential/regulatory documents • Participate in and complete all general and study specific training as required • Participate in investigator, client and project team meetings • Create and implement subject enrollment strategies for assigned study sites • Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials • Perform site management activities and provide ongoing updates of site status to Clinical Project Manager • Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan • Utilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IP • Assist with project-specific activities as member of Project Team • May support in development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.) • May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures • Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available. • Provide regular updates to Sponsor/ Client • Where applicable, support in contract negotiation with study sites, Investigator payments and tracking of site payments • Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans • Identify site issues and implement corrective actions or escalate as appropriate • Liaise with Clinical Data Management for data cleaning activities • Assist in preparing and coordinating Investigator and client meetings and attend meetings as necessary
Job Requirements
- At least 2 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources
- Fluent in English
- Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources
- Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO
- You need to be fully eligible to work in Argentina - CTI does not provide VISA Sponsorship.
Benefits
- Advance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
- Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
- Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.
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