Monitor(a) de pesquisa clínica) jr – São Paulo/SP ou Porto Alegre/RS

SP | São Paulo, RS | Rio Grande do Sul
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Biotecnologista
Farmacêutico
Médico Veterinário

Responsabilidades

• 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.

Requeriments

• 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.