Clinical Research Associate (Monitor(a) de Pesquisa Clínica) I

Job Description

Join Our Team as a Clinical Research Associate (CRA)!

Are you passionate about clinical research and eager to make a positive impact on healthcare? We are looking for a dedicated Clinical Research Associate (CRA) to join our team! In this role, you will be the primary site contact throughout all phases of clinical research studies, with responsibility for allocated sites.

Key Responsibilities:

• Act as the main site contact and manager during all phases of clinical research studies, ensuring compliance with ICH-GCP and organizational policies.
• Develop and maintain strong relationships with study sites to ensure continuity and success throughout the trial.
• Perform clinical study site management and monitoring activities in accordance with ICH-GCP, Sponsor SOPs, local laws, and regulations.
• Gain a comprehensive understanding of study protocols and related procedures.
• Coordinate and manage various tasks in collaboration with other sponsor roles to achieve “Site Ready” status.
• Participate in site selection and validation activities.
• Conduct remote and on-site monitoring to ensure data integrity and the protection of subjects’ rights, safety, and well-being.
• Conduct site visits, including initiation, monitoring, and close-out visits, documenting findings accurately and in a timely manner.
• Collect, review, and manage required regulatory documentation throughout study start-up, maintenance, and close-out phases.
• Communicate effectively with investigators and site staff regarding protocol conduct and overall site performance.
• Identify, assess, and resolve site performance or compliance issues while collaborating with stakeholders.
• Work closely with internal and external teams to support assigned sites and maintain information in relevant systems.
• Support audit and inspection activities as required.
• Perform co-monitoring tasks where appropriate.

Main Requirements:

• Education: Bachelors degree required, with emphasis in life sciences, biology, or related fields.
• Experience: Entry-level experience in clinical research, such as Clinical Trial Assistant, Study Coordinator, or similar roles.
• Languages: Fluent in Portuguese and advanced proficiency in English.
• Effective time management, organizational, and interpersonal skills, with conflict management capabilities.
• Ability to collaborate with experienced research professionals across multiple protocols, sites, and therapy areas.
• High sense of accountability and urgency, with the ability to set priorities and manage multiple tasks in a fast-paced environment.
• Proven ability to work effectively in a multicultural matrix environment while maintaining culturally sensitive working relationships.
• Demonstrates a strong customer focus and a positive growth mindset, capable of working independently.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 75%

Shift: 1st - Day

Job Posting End Date: 04/25/2025

Requisition ID: R341557