Senior Clinical Research Associate – Hematology/Oncology

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

📋 Description

• Lead site qualification, initiation, monitoring, and closeout visits.

• Ensure compliance with study protocols, GCP, and regulatory standards.

• Supervise site performance, data integrity, and patient safety through monitoring and source document verification.

• Proactively identify risks and support adherence to protocols.

• Establish relationships with investigative sites while providing training, guidance, and continuous support.

• Coordinate and review study documentation, regulatory submissions, investigator site files, and updates to the Trial Master File.

• Monitor study milestones, assess deliverables, and assist in operational planning and execution.

• Act as a Lead CRA for global studies.

• Organize monitoring activities and mentor less experienced CRAs.

• Facilitate the resolution of data queries and review both paper and electronic CRFs.

• Ensure timely and accurate collection of study data.

• Participate in study team and investigator meetings, bid defenses, monitoring plans, study-specific tools, and training materials.

• Travel to investigative sites approximately 6–8 days per month.

⛳️ Requirements

• Medical Doctor (MD) or Pharmacy degree with a minimum of 5 years of CRA experience; or a four-year degree in a life science-related field with at least 4 years of CRA experience; or a two-year college curriculum/equivalent training, preferably in nursing or life sciences, with a minimum of 5 years of CRA experience.

• In-depth knowledge of clinical research processes, GCP, ICH guidelines, FDA and/or EU regulations, and relevant local regulatory requirements.

• Experience in independently managing site monitoring activities throughout the clinical trial lifecycle.

• Capacity to function as a Lead CRA.

• Proficient with Microsoft Office, IxRS platforms, and electronic data capture (EDC) systems.

• Ability to mentor and influence others effectively.

• Fluency in the local language(s) relevant to assigned countries.

• Proficiency in both spoken and written English.

• Candidates must reside within the designated territory and be based in Porto Alegre, Curitiba, or Sao Paulo.

• Willingness to travel approximately 6–8 days per month.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Access to learning and professional development resources.

• Flexible home-based/remote work arrangements.

• Opportunity to serve as a Lead CRA.

• Mentoring and training opportunities available.

• Chance to contribute to study planning, training, and operational excellence.