Clinical Research Associate II - Hematology ( Argentina )

Worldwide Clinical Trials; Tandil; A distancia; ARS 1.200.000 - 2.400.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a Clinical Research Associate II to operate on a home‑based basis supporting sites across Argentina. You will monitor across studies, ensure data integrity and regulatory compliance, mentor junior CRAs, and help drive study planning and training efforts.

The role requires MD/Pharmacy or life sciences background with CRA experience, strong GCP knowledge, and English proficiency.

Formación

• Deep knowledge of GCP, ICH guidelines, FDA regulations and local requirements.
• Ability to manage site monitoring across clinical trial lifecycle.
• Experience mentoring junior CRAs and driving study execution.
• Strong communication and organizational skills, with attention to quality and safety.

Responsabilidades

• Lead site qualification, initiation, monitoring and closeout visits per protocol and regulatory standards.
• Oversee site performance, data quality and patient safety through monitoring and source data verification.
• Mentor less experienced CRAs and support training and process improvements.
• Coordinate regulatory submissions, investigator files and trial master file updates for inspection readiness.
• Track milestones with study teams and contribute to operational planning and execution.
• Serve as Lead CRA on global studies and support teams across regions.
• Resolve data queries and review CRFs to ensure timely, accurate data collection.
• Contribute to investigator meetings, training materials and study tools.

Conocimientos

GCP knowledge

Regulatory knowledge

Communication skills

Mentoring

IxRS proficiency

EDC proficiency

English proficiency

Educación

MD or Pharmacy degree

Life science degree

Nursing or life sciences training

Herramientas

IxRS platforms

EDC systems

Descripción del empleo

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as a Clinical Research Associate II- at Worldwide

As a CRA II , you'll play a critical role in advancing clinical research by ensuring studies are delivered with quality, compliance, and patient safety at the forefront. You'll serve as a trusted partner to investigative sites, sponsors, and study teams, helping drive successful study execution from site qualification through closeout.

In this role, you'll take ownership of monitoring activities across multiple studies while supporting data integrity, protocol compliance, and regulatory requirements. You'll also have the opportunity to provide leadership, mentor less experienced CRAs, and contribute to study planning, training, and operational excellence.

Your expertise will help ensure high-quality clinical trial delivery, supporting the development of therapies that can make a meaningful difference for patients worldwide.

Where You'll Work

This is a home-based Clinical Research Associate role supporting sites across Argentina. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 6-10 days per month.

To best support our sites, we're seeking candidates who are based in Argentina. Travel will primarily be regional, with occasional travel to support sites in other locations as needed.

What You'll Do

• Lead site qualification, initiation, monitoring, and closeout visits while ensuring adherence to study protocols, GCP, and regulatory requirements.
• Oversee site performance, data quality, and patient safety through effective monitoring, source document verification, and risk identification.
• Build strong relationships with investigative sites, providing training, guidance, and ongoing support to promote protocol compliance and study success.
• Coordinate and review study documentation, regulatory submissions, investigator site files, and Trial Master File updates to maintain inspection readiness.
• Partner with project teams to track study milestones, evaluate deliverables, and contribute to operational planning and execution.
• Serve as a Lead CRA on global studies by coordinating monitoring activities and supporting less experienced CRAs through mentoring and training.
• Facilitate resolution of data queries, review paper and electronic CRFs, and support timely, accurate study data collection.
• Contribute to study team meetings, investigator meetings, bid defenses, monitoring plans, and the development of study-specific tools and training materials.

What You'll Bring

• Medical Doctor (MD) degree or Pharmacy degree with at least 2 years of Clinical Research Associate experience; OR a four-year degree in a life science-related field with at least 3 years of CRA experience; OR a two-year college curriculum/equivalent training (nursing or life science preferred) with at least 4 years of CRA experience.
• Extensive knowledge of clinical research processes, GCP, ICH guidelines, FDA and/or regulations, and local regulatory requirements.
• Demonstrated experience independently managing site monitoring activities across the clinical trial lifecycle.
• Strong understanding of multiple therapeutic areas and the ability to function as a Lead CRA.
• Experience in full-service monitoring preferred.
• Proficiency with Microsoft Office, IxRS platforms, and electronic data capture (EDC) systems.
• Excellent communication, organization, time management, problem-solving, and relationship-building skills, with the ability to mentor and influence others.
• Fluency in local language(s) required for assigned countries and proficiency in spoken and written English.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.