Clinical Research Associate - All Levels (Porto Alegre)

ICON; Brasil; Presencial; BRL 70.000 - 120.000; Tempo integral

Resumo da oferta

ICON is seeking a Clinical Research Associate to monitor clinical trials, ensure compliance with protocols, and guarantee data integrity. The role includes both onsite and remote activities and requires a Bachelor's degree along with previous clinical trial support experience. Candidates based in São Paulo or Porto Alegre with a willingness to travel are preferred.

Serviços

Continuous learning and professional development

Competitive total rewards package including base pay

Employee benefits and wellbeing initiatives

Qualificações

• Bachelor's degree or equivalent in clinical, science, or health-related fields.
• Previous clinical trial support experience, including solid onsite monitoring.
• Fluency in English and host country language required.

Responsabilidades

• Monitor clinical studies to ensure compliance with protocol and regulations.
• Verify informed consent procedures and protocol adherence.
• Write and submit site visit reports, escalate issues as needed.

Conhecimentos

Clinical trial monitoring

Data integrity

Risk assessment

Onsite monitoring

Regulatory compliance

Formação académica

Bachelor's degree in clinical, science, or health-related fields

Descrição da oferta de emprego

A Clinical Research Associate (CRA) contributes to accelerated drug, device, or outcomes research through independent monitoring of studies to ensure patient safety and data integrity.

Join a program that takes an extensive co-monitoring approach, fostering a supportive and collaborative work environment. Frequent, consistent communication with internal teams and clients ensures alignment on shared goals.

The CRA monitors the progress of clinical studies at investigative sites or remotely, ensuring that trials are conducted, recorded, and reported according to the protocol, SOPs, ICH-GCP guidelines, and regulatory requirements.

• Complete onsite and remote monitoring activities in accordance with ICH-GCP, regulations, SOPs, and study processes, including qualifying sites, initiating trials, maintaining files, instructing site personnel, and study closeout.
• Verify participant protection by confirming informed consent procedures and protocol adherence.
• Ensure data integrity and compliance with the protocol, GCP, regulations, and SOPs.
• Manage investigative site staff to facilitate trial deliverables such as subject enrollment and data submission.
• Verify proper management and accountability of Investigational Products (IP).
• Write and submit site visit reports, escalate issues, and implement corrective actions as needed.
• Manage essential documents per regulations and ICH-GCP guidelines, and assist with data queries.
• Perform risk assessments, site health analysis, and project escalation activities.
• Participate in audit preparations and follow-up activities.
• Perform various onsite and offsite monitoring visits independently.
• Review site information for inconsistencies, assess risks, and escalate issues appropriately.
• Support ad-hoc studies or initiatives and serve as a trainer for less experienced team members.

Qualifications:

• Bachelor's degree or equivalent in clinical, science, or health-related fields; healthcare professional licensure (e.g., registered nurse).
• Previous clinical trial support experience, including solid onsite monitoring.
• Based in São Paulo or Porto Alegre.
• Willingness to travel 50-80%.
• Equivalent education, training, and experience may be considered. Fluency in English and host country language required.

Benefits of Working at ICON:

• We focus on continuous learning and professional development.
• Competitive total rewards package, including base pay, variable pay, and recognition programs.
• Employee benefits, wellbeing initiatives, and policies supporting work-life balance.
• ICON is an equal opportunity employer committed to diversity and inclusion. Accommodations available for applicants with disabilities.