Senior Clinical Research Associate- SR CRA

CTI; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

CTI is seeking a Clinical Research Associate in São Paulo to manage clinical trial sites and ensure compliance with protocols. Applicants need a Bachelor's degree in a relevant field and at least 3 years of experience in trial monitoring. Offering strong career development and a supportive company culture, this role is key to advancing treatment for critically ill patients.

Serviços

Career development through mentoring programs

Education support including tuition reimbursement

Annual cash bonuses

Work-life balance

Qualificações

• At least 3 years of clinical trial monitoring experience.
• Eligibility to work in Brazil without visa sponsorship.

Responsabilidades

• Conduct site visits and manage site activities.
• Collect and review essential regulatory documents.
• Assist with project-specific activities as part of the project team.

Conhecimentos

Clinical trial monitoring

Fluency in English

Regulatory compliance

Data management

Formação académica

Bachelor's Degree in nursing, pharmacy, or health sciences

3-year Nursing Diploma

Descrição da oferta de emprego

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We support clinical research throughout the development lifecycle, from drug concept to commercialization. Headquartered in the Greater Cincinnati, OH region, CTI collaborates with pharmaceutical, biotechnology, and medical device companies worldwide. For more information, visit www.ctifacts.com.

What You’ll Do

• Serve as the 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 related deliverables with quality and within timelines, following the Monitoring Plan and all regulatory requirements, SOPs, and ICH GCP guidelines.
• Assist with study start-up activities, including feasibility assessments, pre-study preparations, and site selection.
• Collect, review, and track essential and regulatory documents.
• Participate in and complete all required general and study-specific training.
• Participate in investigator, client, and project team meetings, which may include presentations.
• Create and implement subject enrollment strategies for assigned sites.
• Ensure proper storage, dispensation, and accountability of Investigational Product (IP) and trial-related materials.
• Perform site management activities and provide ongoing updates to the Clinical Project Manager.
• Conduct remote monitoring activities as per the Monitoring Plan.
• Utilize systems and reports to track subject status, CRFs, source documents, regulatory documents, and IP.
• Assist with project-specific activities as part of the Project Team.
• Participate in developing CRFs and other study documents.
• Translate, customize, and review Patient Information Sheets, Informed Consent forms, protocol summaries, and other documents as required.
• Support Regulatory Affairs in preparing or revising documentation for submissions to Ethics Committees, Regulatory Authorities, and other bodies, following up until approval, and providing regular updates to the Sponsor/Client.
• Assist with contract negotiations, investigator payments, and tracking site payments.
• Manage Investigator Site Files (ISF) and Trial Master Files (TMF) for assigned sites according to SOPs and Monitoring Plans.
• Identify potential site issues and implement corrective actions or escalate as needed.
• Liaise with Data Management for data cleaning activities.
• Serve as a mentor/trainer for CRAs, including conducting training and assessments.
• Act as Lead CRA for assigned projects.

What You Bring

• At least 3 years of clinical trial monitoring experience or equivalent as determined by CTI Management and HR.
• Fluent in English.
• Bachelor's Degree or higher in nursing, pharmacy, health/natural sciences, or RN with an Associate's Degree, or a 3-year Nursing Diploma with at least 2 years of clinical nursing experience, or equivalent experience as determined by CTI.
• Previous experience in clinical research in hospital settings, pharmaceutical companies, or CROs.
• Eligibility to work fully in Brazil; CTI does not sponsor visas.
• The role is based in São Paulo, in an office setting.

Why CTI?

• Career development through structured mentoring programs.
• Support for education and training, including tuition reimbursement and partnerships with educational institutions.
• Strong company culture with no layoffs in 20 years, work-life balance, and annual cash bonuses.
• Recognition as one of the best places to work in the Cincinnati area and a top CRO in the industry.
• Global philanthropic initiatives, including the “CTI Cares” program.
• Consistent growth, investment in technology, and high employee retention rates.
• Impactful work focusing on treatments for critically and chronically ill patients.

Important Note

Due to recent hiring scams, if you're selected for the next phase, a team member will contact you from an @ctifacts.com email address. Please apply only through our website (www.ctifacts.com) or our verified LinkedIn page.

We will never contact you via Microsoft Teams or SMS, nor ask for bank details during recruitment.