Clinical Research Associate I – FSP, Oncology Experience

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Assist in the identification of potential investigators.

• Provide support during study start-up and maintain regulatory activities as needed.

• Educate, assist, and counsel investigators and site personnel on study-related topics, including RbQM principles.

• Verify and document necessary training for site staff, including ICH-GCP training.

• Engage in Local Study Team and National Investigators meetings as appropriate.

• Initiate, oversee, and finalize study sites in accordance with client procedures.

• Communicate patient recruitment and site progress updates within the Local Study Team.

• Enhance site performance by identifying, addressing, and escalating study-related challenges.

• Update the CTMS and other systems with data related to study sites.

• Oversee study supplies, medication supplies, and drug accountability.

• Conduct remote and on-site monitoring visits, as well as remote data verifications.

• Execute SDR, CRF evaluations, and SDV in line with the Monitoring Plan.

• Carry out Site Quality Risk Assessments and modify monitoring intensity accordingly.

• Ensure prompt resolution of data queries and collaborate with data management to ensure study data quality.

• Guarantee accurate and timely reporting and follow-up of Serious Adverse Events.

• Prepare and complete monitoring visit reports in CTMS and provide feedback to Principal Investigators.

• Follow up on unresolved site actions.

• Escalate systematic or significant quality, privacy, and compliance concerns.

• Aid sites in keeping inspection-ready ISFs.

• Prepare for and cooperate during audits and regulatory inspections.

• Gather and upload essential documents to the eTMF and assist in QC checks.

• Ensure study documents are prepared for final archiving and completion of the local eTMF.

• Provide pertinent research, site, investigator, and competing-study information for the local market.

• Ensure adherence to ethics, company policies, legislation, and applicable regulations.

• Collaborate with local MSLs as directed.

⛳️ Requirements

• Bachelor's degree in a related field, ideally in life sciences, or an equivalent qualification (*).

• Strong understanding of international guidelines such as ICH-GCP.

• Basic knowledge of GMP/GDP.

• Familiarity with relevant local regulations.

• Solid medical knowledge and an ability to learn about the relevant therapeutic areas of the client.

• Basic comprehension of the drug development process.

• Good understanding of Clinical Study Management, including monitoring, study drug handling, and data management.

• Exceptional attention to detail.

• Strong written and verbal communication skills.

• Solid collaboration and interpersonal abilities.

• Effective negotiation skills.

• Willingness to travel nationally/internationally as required.

• Prior experience in oncology is mandatory.

• Capability to understand and utilize computer systems/software in a digital environment.

🏝️ Benefits

• Fixed-term assignment lasting 9–12 months.

• Flexibility for remote work arrangements.

• Opportunity to work with remote collaborators.

• Chance to contribute to therapies that have a positive impact on patients.

• Collaboration with global and local study teams.