cra ii/iii

WHY CHOOSE MEDSIR

We are a Barcelona-based fastest-growing company founded by scientific experts . We are dedicated to the
design and management of innovative strategic clinical trials in oncology,
from study conception to the publication of study results . Together, we create the best strategies that are both clinically relevant and scientifically meaningful . We strive to improve our knowledge of this complex disease and the vast array of available treatments in a fast-innovative way .

At MEDSIR, you will have the job of your life while working together towards our shared mission bringing novel treatments to cancer patients worldwide. We welcome top performers that will bring new ideas, diverse perspectives, and provide you the opportunities and freedom to grow and make a real impact in patients' lives and science… all while having great fun .

About The Opportunity
As a
Clinical Research Associate (CRA) II/III
, you will play a key role in ensuring the successful execution of oncology clinical trials. You will
combine on-site monitoring activities (if needed) with leadership responsibilities
, acting as a liaison between sites, CRAs and cross-functional teams.

HOW YOU WILL CONTRIBUTE:

• Site Monitoring Support & Training: Conduct pre-study, initiation, routine monitoring, and close-out visits to ensure protocol compliance, ICH-GCP, and regulatory requirements. Provide guidance and training to site staff on recruitment strategies, protocol updates, and data entry practices.
• Patient Safety & Data Integrity: Oversee patient recruitment and enrolment processes, review source documentation, CRFs/eCRFs, and resolve data discrepancies in collaboration with site staff and cross-functional teams.
• Investigational Medicinal Product (IMP) Oversight: Manage IMP logistics end-to-end, including forecasting, shipment coordination, and accountability. Ensure proper handling, storage, and chain-of-custody compliance, and address discrepancies identified by CRAs or site personnel.
• Vendor & Sample Management: Coordinate patient sample collection, shipment, and tracking with central laboratories and vendors. Ensure documentation accuracy and resolve operational challenges promptly.
• Query Resolution & Documentation: Collaborate with site staff to reconcile discrepancies, maintain audit-ready documentation, and adhere to established timelines for query closure. Consolidate updates from CRAs, central labs, and vendor portals to maintain a real-time overview of outstanding items. Work closely with Medical Monitors (MM) and cross-functional teams to prioritize and resolve queries, ensuring minimal impact on study timelines and patient safety.
• Stakeholder Engagement & Communication: Act as the principal liaison with investigators, site coordinators, CRAs, Medical Monitors, and other stakeholders. Facilitate clear communication and timely updates on recruitment, site performance, and study progress.
• Protocol & Regulatory Compliance: Confirm site compliance with ICH-GCP, local regulations, and protocol-specific requirements. Identify and document protocol deviations or violations, collaborating with site teams on corrective and preventive actions.
• Risk & Quality Management: Proactively identify risks and protocol deviations, perform root-cause analysis, and collaborate with QA and Project Managers on corrective and preventive actions (CAPAs). Ensure inspection readiness through comprehensive documentation in the Trial Master File (TMF) and Investigator Site File (ISF).
• Trial Communication: Lead the preparation of study newsletters, investigator updates, and other communication materials to ensure sites remain informed of safety alerts, milestones, and protocol amendments.
• Documentation & Reporting: Maintain up-to-date the essential documents in the trial master file (TMF) and Investigator Site File (ISF).
• Support inspection readiness by ensuring traceability of all site-level actions and a thorough record of trial activities, if needed.

WHAT DO WE VALUE FOR THIS OPPORTUNITY?

• Bachelor's degree in Life Sciences, Clinical Research, Nursing, Pharmacy, or a related field.
• At least 2 years of experience in site monitoring or clinical trial coordination (e.g., CRA, Study Coordinator, or similar role).
• Previous experience in oncology clinical trials.
• Strong knowledge of GCP, ICH guidelines, and local/international regulatory requirements.
• Proficiency in electronic data capture (EDC) systems, query resolution, and essential document management.
• Effective communication and interpersonal skills.
• Excellent organizational and time-management abilities, capable of juggling multiple sites and studies.
• Attention to detail and problem-solving proficiency, ensuring patient safety and data reliability.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Fluency in English.
• Excellent organizational skills with demonstrated ability to execute support on projects on time and on budget.

THE THINGS YOU REALLY WANNA KNOW
:

At MEDSIR, we believe that employees today want to evolve in collaborative, high-growth environments where they can demonstrate their abilities and thrive both professionally and personally. We are convinced that employees need to find alignment between their inner values and their company's culture and mission to unlock their full potential. We work to create a culture of empowerment, continuous learning and growth where everyone can bring expertise, own projects and easily measure their impact.

Benefits
Work with world-renowned clinicians and KOL's on high-level publications and papers.

Fast growth, we are an early-stage company with a multidisciplinary team and many growth opportunities.

Work-life balance - hybrid working model and flexible hours focusing on performance rather than office hours.

Unlimited access to GoodHabitz courses and regular workshops (external & internal) to continue your development.

Opportunities to participate in scientific conferences & events at national and international level.

Private health Insurance (AXA).

Work-from-abroad policy depending on position and local legislation.

A young & international team with a company culture focused on development.

Positive, dynamic, and passionate work environment.

Elevate your wellness with Wellhub (formerly GymPass) One subscription for the best in fitness, mindfulness, therapy, nutrition, and sleep support—all in one place.

"Flexible compensation plan" to help you save taxes and increase your net salary (Cobee).

A free day on your birthday so you can truly celebrate

Unforgettable MEDSIR events and regular get togethers.

Equal employment opportunity, at MEDSIR we proudly pursue a diverse workforce and celebrate our differences.

A fantastic workplace located in 22@, Barcelona's new hub of innovation.

We work with MacBook computer (Apple).

If you believe you match our values, you are unique and feel ready to make a change, we look forward to meeting you
We are committed to fostering a diverse and inclusive workplace, where all individuals are treated with respect and equality, regardless of race, gender, age, religion, disability, or any other characteristic. We believe in providing equal opportunities for all and do not tolerate discrimination in any form.