Senior Clinical Research Associate

The role of Clinical Research Associate is to serve as the main contact for assigned study sites, conducting site visits and completing deliverables with quality and within given timelines. This position requires proficiency in English and a strong understanding of clinical trial monitoring procedures.

The ideal candidate will have at least 3 years of clinical trial monitoring experience and a Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health/natural science. Previous experience in conducting clinical research studies in a hospital setting, pharmaceutical company, or CRO is also desirable.

Responsibilities:

• Serve as main CTI contact for assigned study sites
• Conduct site visits and complete site visit deliverables with quality and within given timelines
• 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; may include presentations
• 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 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 Monitoring Plan, etc.
• Participate in the development of CRFs and other study-related documents (subject worksheets, Monitoring Plan, etc.)
• Perform 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/Clien
• 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 and anticipate site issues and implement corrective actions or escalate as appropriate
• Liaise with Clinical Data Management for data cleaning activities
• Serve as mentor/trainer for CRAs; may include conducting training/assessment visits
• Function in the role of Lead CRA for assigned projects

Requirements:

• At least 3 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 Brazil - CTI does not provide VISA Sponsorship
• The role is meant in a office-based setting in São Paulo
• Proficiency in Spanish is considered an asset

Benefits:

• We support career progression – We have a structured mentoring program to provide the support you need to move forward
• We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
• We think globally and act locally – We have a global philanthropic program supporting our team's efforts to improve their local communities
• We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate

Others:

CTI offers a dynamic and supportive work environment that encourages professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.