Clinical Research Associate

Planet Pharma; Argentina; Híbrido; ARS 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Planet Pharma is seeking an experienced Clinical Research Associate to support a growing portfolio of trials across Argentina. The role involves monitoring sites, ensuring adherence to ICH-GCP, study protocols, and local regulations, and maintaining data quality and patient safety.

You will work with cross-functional teams including Clinical Operations, Regulatory Affairs, and Project Management, conduct site initiation, monitoring, and close-out visits, and build strong investigator

Formación

• Experience as CRA in Argentina.
• Strong knowledge of ICH-GCP and local regulations.
• Fluent English (written and spoken).

Responsabilidades

• Conduct site initiation, routine monitoring, and close-out visits
• Oversee site performance, compliance, and data quality
• Build and maintain relationships with investigators and site personnel
• Ensure adherence to protocols, ICH-GCP, and local regulatory requirements
• Review essential study documentation and support regulatory submissions
• Identify site-level risks and implement mitigation strategies
• Support study timelines, enrolment objectives, and project delivery
• Collaborate with Clinical Operations, Regulatory Affairs, and Project Management
• Maintain monitoring reports and study documentation
• Act as a trusted partner to investigative sites

Conocimientos

ICH-GCP knowledge

Site monitoring

Regulatory compliance

Data quality

English fluency

Educación

Degree in Life Sciences or related

Clinical Research certification

Herramientas

EDC software

CTMS

SAS/SPSS

Descripción del empleo

My client, a leading global organisation is seeking an experienced Clinical Research Associate (CRA) to support a growing portfolio of clinical trials across Argentina.

This is an exciting opportunity to join a highly collaborative international team delivering innovative studies for pharmaceutical, biotechnology, and medical device clients. The successful candidate will play a key role in ensuring clinical trials are conducted in accordance with regulatory requirements, ICH-GCP guidelines, and study protocols while maintaining the highest standards of data quality and patient safety.

Key Responsibilities

• Conduct site initiation, routine monitoring, and close-out visits
• Oversee site performance, compliance, and data quality throughout the study lifecycle
• Build and maintain strong relationships with investigators and study site personnel
• Ensure adherence to study protocols, ICH-GCP guidelines, and local regulatory requirements
• Review essential study documentation and support regulatory submissions where required
• Identify site-level risks and proactively implement mitigation strategies
• Support study timelines, enrolment objectives, and overall project delivery
• Collaborate closely with cross-functional teams including Clinical Operations, Regulatory Affairs, and Project Management
• Maintain accurate monitoring reports and study documentation
• Act as a trusted partner to investigative sites, providing guidance and support throughout trial execution

Requirements

• Previous experience working as a Clinical Research Associate within Argentina
• Strong understanding of ICH-GCP and local clinical trial regulations
• Experience conducting on-site and remote monitoring activities
• Proven ability to manage investigator sites and stakeholder relationships effectively
• Strong organisational, problem-solving, and communication skills
• Ability to work independently while collaborating within a global team environment
• Demonstrated ability to identify and resolve issues in a proactive manner
• Fluent English language skills, both written and verbal
• Degree in Life Sciences, Pharmacy, Nursing, or a related discipline preferred

Interested? Apply now for immediate consideration or contact Michael Owusu-Ansah on [phone] – [e-mail]

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.