Senior Clinical Research Associate

Upsilon Global; Buenos Aires; On-site; ARS 1,200,000 - 1,800,000; Full time

Job summary

Upsilon Global is seeking a Senior Clinical Research Associate / CRA II to join their clinical operations team on a permanent basis in Argentina. The role involves monitoring sites across Argentina and internationally, ensuring ICH-GCP compliance, and collaborating with global study teams.

Travel within Argentina and occasional international travel are required. Ideal candidates have at least 2 years of CRA experience, strong monitoring skills, and fluency in Portuguese and English, with ability

Qualifications

• Minimum of 2 years' experience as a Clinical Research Associate.
• 2+ years clinical trial monitoring experience and independent monitoring visits.
• Experience with interventional trials and SDV/SDR.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Experience across the full study lifecycle and site management.

Responsibilities

• Conduct Site Selection, Site Initiation, Monitoring and Close-Out visits.
• Monitor sites per protocol, sponsor requirements and regulations.
• Perform SDV/SDR and ensure data quality and patient safety.
• Review informed consent and manage protocol deviations and risks.
• Provide guidance to investigators and maintain robust site communications.
• Prepare monitoring reports and ensure inspection-ready documentation.
• Support study start-up, recruitment, maintenance and close-out activities.

Skills

Site monitoring

Independent monitoring visits

SDV / SDR

Regulatory compliance

ICH-GCP knowledge

Study lifecycle experience

Site issue resolution

Communication with sites

Travel readiness

Team collaboration

Tools

Veeva

Oracle

Medidata RAVE

CTMS

eTMF systems

MS Word

MS Excel

MS PowerPoint

MS Project

Job description

Upsilon Global is supporting the growth of an established international medical-device organisation with an expanding clinical research portfolio.

We are currently seeking an experienced Senior Clinical Research Associate / CRA II to join the clinical operations team on a permanent basis, supporting the successful delivery of clinical studies across Argentina and internationally.

This opportunity would suit a clinical research professional with strong monitoring experience who is looking to take greater ownership of their work, collaborate closely with international study teams, and gain broader exposure within a growing medical-device organisation.

POSITION DETAILS

Position: Senior Clinical Research Associate / CRA II

Location: Argentina

Contract: Permanent

Start Date: January

Experience: Minimum 2 years of clinical trial monitoring experience

Languages: Portuguese and English

Travel: Regular travel within Argentina, with occasional international travel

ABOUT THE OPPORTUNITY

The organisation combines scientific expertise with strong operational delivery and close collaboration across international clinical research teams.

The successful candidate will be responsible for supporting clinical trial sites throughout the study lifecycle, from study start-up through to close-out. This will include conducting monitoring visits, maintaining strong site relationships, ensuring compliance with study protocols and applicable regulations, and supporting overall study quality.

The role provides an opportunity to work within a growing organisation where clinical research professionals can have meaningful involvement in their projects and broader exposure to the organisation's activities.

KEY REQUIREMENTS

• Minimum of 2 years' experience working as a Clinical Research Associate
• Minimum of 2 years' clinical trial monitoring experience
• Experience conducting independent monitoring visits
• Experience with interventional clinical trials
• Strong knowledge of ICH-GCP, clinical trial regulations and monitoring practices
• Experience across the clinical trial lifecycle, from study start-up through to close-out
• Experience conducting Site Selection Visits, Site Initiation Visits, Monitoring Visits and Close-Out Visits
• Strong understanding of Source Data Verification (SDV) and Source Data Review (SDR)
• Experience working with investigators, study coordinators and clinical trial sites
• Strong organisational and time-management skills
• Excellent attention to detail and commitment to quality
• Strong problem-solving skills and a proactive approach to identifying and resolving site issues
• Ability to work independently while contributing effectively to an international study team
• Strong written and verbal communication skills
• Fluency in Portuguese and English
• Willingness and ability to travel regularly within Argentina and occasionally internationally

KEY RESPONSIBILITIES

The successful candidate will be responsible for:

• Conducting Site Selection Visits, Site Initiation Visits, Monitoring Visits and Close-Out Visits
• Monitoring clinical trial sites in accordance with study protocols, sponsor requirements, ICH-GCP and applicable regulations
• Conducting Source Data Verification and Source Data Review to ensure data quality and accuracy
• Reviewing informed consent documentation and supporting appropriate patient safety and subject protection
• Identifying, documenting and following up on protocol deviations, site issues and study-related risks
• Providing support and guidance to investigators and site staff regarding study requirements
• Maintaining effective communication with investigators, study coordinators, sponsors and internal study teams
• Preparing accurate and high-quality monitoring reports within required timelines
• Ensuring essential regulatory and study documentation is complete, accurate and inspection ready
• Supporting risk-based monitoring activities and overall study quality oversight
• Supporting study start-up, recruitment, study maintenance and close-out activities
• Monitoring site performance and following up on outstanding actions
• Reviewing CRFs, Investigator Site Files and other essential study documentation
• Supporting regulatory submissions and approvals where required
• Supporting the resolution of audit findings and implementation of corrective actions
• Ensuring adverse events and serious adverse events are appropriately documented and followed up
• Supporting the reconciliation and close-out of study materials, documentation and site activities

SYSTEMS AND TECHNICAL EXPERIENCE

Experience with clinical research systems and software would be beneficial, including:

• Veeva
• Oracle
• Medidata RAVE
• CTMS
• eTMF systems
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• MS Project

The successful candidate should also be comfortable learning and working with clinical research systems and maintaining accurate documentation within required timelines.

ADDITIONAL SKILLS

We are looking for a professional who demonstrates:

• Strong interpersonal and relationship-building skills
• Excellent communication with clinical research sites and study stakeholders
• The ability to manage multiple priorities effectively
• Strong problem-solving and decision-making skills
• A proactive approach to site management and issue resolution
• High attention to detail
• A strong understanding of clinical trial quality and compliance requirements
• The ability to build and maintain effective relationships with investigators and site teams
• The ability to collaborate with colleagues and stakeholders across different countries and cultures
• A flexible and adaptable approach to working within a growing clinical research environment
• A client-focused mindset and commitment to delivering high-quality work within agreed timelines

WHY CONSIDER THIS OPPORTUNITY?

As a smaller medical-device organisation, this role offers:

• Greater visibility and ownership across clinical research activities.
• Closer access to senior leadership and key decision-makers.
• Direct exposure to product development and the impact of clinical research.
• Broader responsibilities and professional exposure across the organisation.
• Strong career development opportunities within a growing environment.