Clinical Research Associate I

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

📋 Description

• Complete the necessary CRA Training Program, which encompasses instructor-led training, independent exercises, and in-field observation visits.

• Execute site visits, including PSSV, SIV, IMV, and COV, while serving as the site manager.

• Establish and nurture relationships with key personnel at sites to ensure effective communication.

• Oversee data quality and patient safety through monitoring and educating site staff.

• Carry out and coordinate clinical monitoring activities in line with GCPs, SOPs, local regulations, and monitoring plans.

• Conduct site visits to evaluate compliance with protocols and regulations, preparing the necessary documentation.

• Deliver protocol and study-related training to designated clinical study sites.

• Monitor enrollment, CRF data entry, protocol deviations, and site-related issues.

• Relay site performance updates to the Clinical Study Team.

• Provide mentorship or training to less experienced CRAs when necessary.

• Facilitate study-specific training sessions with the project team.

• Reconcile Serious Adverse Events and address discrepancies with study sites and the CST.

• Collaborate with the CST and sites to achieve study milestones, including startup, recruitment, database analyses, and closeout.

• Participate in investigator meetings and site booster visits as needed.

• Assist in audit and inspection preparation, ensuring quality findings are resolved.

• Offer site-level management, co-monitoring, and support for assigned study sites.

⛳️ Requirements

• BS/BA in a pertinent scientific discipline.

• A minimum of 1 year of experience in a clinical research associate role is preferred.

• Over 5 years of relevant Clinical Operations experience or experience in oncology global trials is preferred.

• Outstanding communication and interpersonal skills.

• Strong organizational skills with the capability to prioritize and manage multiple tasks.

• Proficient in English, both written and spoken.

• Willingness to travel up to 70% of the time.

• Competency in Microsoft Word, Excel, PowerPoint, and Outlook.

• Familiarity with industry software such as CTMS, investigational product systems, and data management systems.

🏝️ Benefits

• Comprehensive training and development opportunities.

• Collaborative and supportive work environment.

• Competitive salary and benefits package.