Clinical Research Associate II - Transplant and Transfusion

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care

A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards

Key Accountabilities

• Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
• Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution.
• Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle.
• Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies.
• Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records.
• Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly.
• Assist in managing study timelines, budgets, and deliverables, escalating risks.
• Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications.
• Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies
• Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician)
• Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed

Minimum Knowledge & Experience required for the position:

• Bachelor's degree in life sciences or related field (Medical Technology, Biology.)
• Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO
• Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR)
• Excellent understanding of clinical trial design

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Demonstrates strong regulatory knowledge to maintain compliance across global studies.
• Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution.
• Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes.
• Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment.
• Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines.
• Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure.

Travel requirements:Will vary by project. Travel requirement could be approx. 20%

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com