Clinical Research Associate II – Hematology

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

📋 Description

• Lead the process of site qualification, initiation, monitoring, and closeout visits.

• Ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory standards.

• Oversee site performance, data integrity, and patient safety through monitoring, source document verification, and risk assessment.

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

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

• Collaborate with project teams to track study milestones, assess deliverables, and assist in operational planning and execution.

• Act as a Lead Clinical Research Associate (CRA) for global studies.

• Organize monitoring activities while mentoring and training junior CRAs.

• Facilitate the resolution of data queries and review both paper and electronic Case Report Forms (CRFs).

• Support the timely and accurate collection of study data.

• Contribute to study team meetings, investigator meetings, bid defenses, monitoring strategies, study-specific tools, and training materials.

• Travel regionally to investigative sites, with occasional travel to other locations as required.

⛳️ Requirements

• A Medical Doctor (MD) degree or a Pharmacy degree with a minimum of 2 years of experience as a Clinical Research Associate; OR a four-year degree in a life sciences-related discipline with at least 3 years of CRA experience; OR a two-year college curriculum/equivalent training (preferably in nursing or life sciences) with a minimum of 4 years of CRA experience.

• Comprehensive knowledge of clinical research processes, GCP, ICH guidelines, FDA regulations, and local regulatory requirements.

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

• Strong understanding of various therapeutic areas and the capability to serve as a Lead CRA.

• Proficiency in Microsoft Office, IxRS platforms, and electronic data capture (EDC) systems.

• Exceptional communication, organizational, time management, problem-solving, and relationship-building skills.

• Ability to mentor and influence others effectively.

• Fluency in local language(s) required for the assigned countries.

• Proficiency in spoken and written English.

• Must be a resident of Argentina.

• Willingness to travel to investigative sites approximately 6–10 days per month.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Chance to learn and advance professionally.

• Mentoring and training opportunities available.

• Home-based or remote work arrangement.