22 oct
|
Upsilon Global
|
Provincia de Buenos Aires
22 oct
Upsilon Global
Provincia de Buenos Aires
Senior Clinical Research Associate / CRA II – Oncology | Argentina | Permanent
Upsilon General is supporting the growth of an established international medical-device organisation with an expanding clinical research portfolio and a strong focus on Oncology.
We are seeking an experienced Senior Clinical Research Associate / CRA II to join a well-rounded, collaborative clinical operations team, supporting the delivery of Oncology-focused clinical studies across Argentina and internationally.
This is an opportunity to work alongside experienced clinical research professionals and international study teams, contributing to the successful execution of clinical trials in a highly specialised therapeutic area. The role offers the opportunity to take ownership of site management activities, contribute to study quality and compliance, and gain broader exposure within a growing medical-device organisation.
The successful candidate will combine strong monitoring expertise with a proactive, quality-driven approach, building effective relationships with investigators and site staff while supporting the delivery of clinical studies throughout the trial lifecycle.
POSITION DETAILS:
Position: Senior Clinical Research Associate / CRA II
Therapeutic Focus: Oncology
Location: Argentina
Contract: Permanent
Start Date: January
Experience: Minimum 2 years of clinical trial monitoring experience
Languages: Spanish and English
Travel: Regular travel within Argentina, with occasional international travel
ABOUT THE OPPORTUNITY:
The organisation combines scientific expertise, clinical innovation and strong operational delivery, with an emphasis on collaboration across international clinical research teams.
With a particular focus on Oncology, this position offers the opportunity to contribute to clinical studies within a demanding and impactful therapeutic area while working alongside a well-rounded team of clinical research professionals. The successful candidate will play an important role in maintaining site performance, safeguarding data quality and supporting compliance throughout the clinical trial lifecycle.
From study start-up through to close-out, the role involves close engagement with investigators, study coordinators, sponsors and internal stakeholders. It is well suited to a clinical research professional seeking greater ownership of their work, meaningful involvement in study delivery and broader exposure within an expanding medical-device environment.
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, preferably within Oncology.
- 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, time-management and problem-solving skills.
- Excellent attention to detail and commitment to clinical quality and compliance.
- 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 support data quality, accuracy and integrity.
- Reviewing informed consent documentation and supporting patient safety and participant protection.
- Identifying, documenting and following up on protocol deviations, site issues and study-related risks.
- Providing guidance to investigators and site staff on study requirements and procedures.
- Maintaining effective communication with investigators, study coordinators, sponsors and internal clinical operations teams.
- Preparing accurate, 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.
- Contributing to study start-up, recruitment, study maintenance and close-out activities.
- Monitoring site performance and following up on outstanding actions.
- Reviewing Case Report Forms (CRFs), Investigator Site Files and other essential study documentation.
- Supporting regulatory submissions and approvals where required.
- Assisting with the resolution of audit findings and implementation of corrective and preventive 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
- Clinical Trial Management Systems (CTMS)
- Electronic Trial Master File (eTMF) systems
- Microsoft Word, Excel and PowerPoint
- Microsoft Project The successful candidate should also be comfortable learning new clinical research systems and maintaining accurate, complete documentation within required timelines.
ADDITIONAL SKILLS
We are looking for a professional who demonstrates:
- Strong interpersonal and relationship-building capabilities.
- Effective communication with clinical research sites and study stakeholders.
- The ability to manage multiple priorities and competing deadlines.
- Sound problem-solving and decision-making skills.
- A proactive approach to site management and issue resolution.
- High attention to detail and a commitment to quality.
- A strong understanding of clinical trial compliance and patient safety requirements.
- The ability to establish and maintain productive relationships with investigators and site teams.
- A collaborative approach to working with colleagues and stakeholders across different countries and cultures.
- Flexibility and adaptability within a growing clinical research environment.
- A client-focused mindset and commitment to delivering high-quality work within agreed timelines.
WHY CONSIDER THIS OPPORTUNITY?
Joining a growing medical-device organisation offers the opportunity to contribute meaningfully to clinical research while working within a collaborative international environment.
Key benefits include:
- Oncology-focused experience: Contribute to clinical studies within a specialised and important therapeutic area.
- Collaborative team environment: Work closely with a well-rounded clinical operations team and international study stakeholders.
- Greater ownership: Take responsibility for site management activities and contribute directly to study delivery.
- Broader organisational exposure: Gain insight into clinical operations, medical-device development and wider business activities.
- Closer stakeholder engagement: Build relationships with senior colleagues, investigators and key decision-makers.
- Career development: Expand your clinical research expertise within a growing international organisation.
- Permanent opportunity: Establish yourself within a team supporting the continued expansion of its clinical research portfolio.
INTERESTED IN DISCUSSING THE OPPORTUNITY?
If you are an experienced CRA II or Senior CRA with at least two years of clinical trial monitoring experience, fluency in Portuguese and English, and an interest in Oncology-focused clinical research, we would welcome the opportunity to speak with you.
Please apply directly through the LinkedIn advert or contact Upsilon Global on +44 (phone hidden) for a confidential discussion about the position.
Upsilon Global connects clinical research professionals with opportunities across the clinical development sector.
📌 Senior Clinical Research Associate (Provincia de Buenos Aires)
🏢 Upsilon Global
📍 Provincia de Buenos Aires