What are the responsibilities and job description for the Clinical Research Associate II - Transplant and Transfusion position at Werfen?
Overview
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
Responsibilities
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
Qualifications
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%