Senior Clinical Research Associate
Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end\-to\-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.
About This Role
Veranex is excited to offer an opportunity to join our growing Clinical Operations team as a Senior Clinical Research Associate (Sr CRA). In this role, you will support innovative medical device studies across Germany and potentially throughout Europe. You will play a critical role in ensuring the high\-quality execution of clinical trials in compliance with applicable regulations, Good Clinical Practice (GCP), and company standards.
As a Sr CRA, you will serve as a key liaison between sites, the sponsor and the internal study team, leveraging your expertise in monitoring, regulatory compliance, and site management. You will contribute to the planning, development, and execution of clinical trials to evaluate the safety, effectiveness, and performance of medical devices.
What You Will Do
- Perform site selection, initiation, monitoring, and close\-out visits in accordance with Clinical Investigation Plans (CIPs), monitoring plans, GCP, and Standard Operating Procedures (SOPs).
- Ensure clinical studies are conducted in compliance with the CIP, GCP, and applicable regulations such as EU MDR.
- Build and maintain strong relationships with investigators and site staff.
- Monitor data quality, subject safety, and protocol adherence throughout the study lifecycle.
- Support investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.
- Identify and escalate risks, issues, and protocol deviations proactively.
- Support regulatory submissions and ethics committee interactions.
- Review and ensure accuracy and completeness of clinical documentation
- Contribute to CIP, informed consent, Case Report Form (CRF) and study plan development as well as annual progress reports (APRs) and the Clinical Investigation Report (CIR) at study conclusion to report the study results to Regulatory Authorities and other relevant parties.
- Drive trial enrollment and identify and communicate potential and actual obstacles to enrollment.
- Mentor junior CRAs and contribute to process improvements
- Collaborate cross\-functionally with Clinical Operations, Medical Affairs, and Regulatory teams.
Required:
- BS or BA in a relevant scientific discipline
- Minimum of 5 years of directly related work experience or equivalent in clinical research, including proven experience in medical device studies.
- Must be able to work autonomously and as a member of a cross\-functional team and meet high expectations and tight deadlines. May work on highly visible projects in high\-pressure situations.
- Must have working knowledge of GCP, including ISO 14155, and the EU MDR.
- Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail.
- Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross\-functionally, and with clients/partners.
- Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint; as well as experience with Electronic Data Capture (EDC) and electronic Trial Master File (eTMF) systems.
- Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments.
- Familiarity with medical and anatomical terminology.
- Fluency in both German and English is required; additional language skills are an advantage.
- Ability and willingness to travel (travel requirement: 25\-50%)
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