Senior Clinical Research Associate

Veranex Inc.; Germany (OH); On-site; USD 80,775 - 103,853; Full time

Job summary

Veranex Inc. is seeking a Senior Clinical Research Associate (Sr CRA) to join our Clinical Operations team. You will support medical device studies across Germany, ensuring compliance with regulations and quality standards.

Responsibilities include site selection, monitoring, relationship management, and ensuring data quality throughout clinical trials. Candidates should have a BS/BA degree, at least 5 years in clinical research, and fluency in German and English. Join us to make a real impact in the field!

Qualifications

• Minimum of 5 years of experience in clinical research.
• Proven experience in medical device studies.
• Ability to work autonomously and in a team.
• Strong attention to detail.

Responsibilities

• Perform site selection, initiation, monitoring, and close-out visits.
• Ensure compliance with regulations such as EU MDR.
• Build and maintain relationships with investigators.
• Monitor data quality and subject safety.
• Support regulatory submissions and ethics committee interactions.

Skills

Project management competencies

Communication skills

GCP knowledge

Microsoft Office Suite

Fluency in German

Fluency in English

Education

BS or BA in a relevant scientific discipline

Tools

Electronic Data Capture (EDC)

Electronic Trial Master File (eTMF)

Job description

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, monitoring plans, GCP, and Standard Operating Procedures.
• 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 escalation 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.

Qualifications

• 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%).

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.