Senior Clinical Research Associate

Jobtailor; Deutschland; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced Clinical Research Professional in Germany to lead monitoring across medical device trials. You will ensure adherence to protocol, GCPs, CFRs, and IRB/EC requirements while training site staff and coordinating regulatory reporting.

The role requires autonomous work within cross-functional teams, strong project management, and willingness to travel to sites to drive trial enrollment and data quality.

Qualifikationen

• Minimum of 5 years in clinical research.
• Experience with medical device trials (IDE) and site monitoring.
• Strong knowledge of GCPs, FDA regulations, and IRB/EC requirements.
• Ability to work autonomously within cross-functional teams and meet tight deadlines.

Aufgaben

• Ensure investigators and coordinators comply with the study protocol, GCPs, CFRs, and IRB/EC requirements; train and guide staff.
• Conduct site qualification visits, start-up activities, monitoring and close-out visits; generate reports per the Clinical Monitoring Plan.
• Contribute to protocol, informed consent, CRF and study plan development and regulatory reporting to authorities.
• Maintain data quality and integrity via adverse event review, data trending, and corrective actions.
• Support SOPs, TMF/document control and device traceability activities.
• Travel as needed to clinical sites and meetings.

Kenntnisse

Clinical Research Management

Good Clinical Practices (GCPs)

Project Management

Electronic Data Capture (EDC)

TMF Management

Regulatory Reporting

Data Quality Assurance

Communication

Team Collaboration

Tools

Microsoft Office Suite

eTMF systems

Clinical Monitoring Plan

Jobbeschreibung

• Responsible for ensuring that study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow‑up of corrective actions
• Acts as primary liaison to clinical sites.
• Conducts site qualification visits, study start‑up activities (essential document collection), site qualification visits, site initiation visits and training, monitoring visits for source data verification (reported study data are accurate, complete, and verifiable from source documents in the site’s medical records), and site close‑out visits. Generates high‑quality site qualification, initiation, monitoring, and close‑out visit reports in timely manner (in accordance with the Clinical Monitoring Plan)
• Contributes to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities
• Ensures that the rights and well‑being of human subjects are protected and confirms data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary
• Supports maintenance of department SOPs and work instructions
• Supports investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.
• Supports and maintains documentation of all clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information.
• Drives trial enrollment and identifies and communications potential and actual obstacles to enrollment.

Requirements

• Minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non‑significant risk abbreviated IDE trials.
• 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 Good Clinical Practices (GCPs), FDA regulations and IRB requirements.
• 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.
• Ability and willingness to travel

Core Competencies

Demonstrates expertise in clinical research management, ensuring compliance with Good Clinical Practices (GCPs), FDA regulations, and IRB requirements. Proficient in project management, data integrity, and effective communication across cross‑functional teams.

Highest‑signal resume keywords

• Clinical Research Management
• Good Clinical Practices (GCPs)
• Project Management
• Electronic Data Capture (EDC)
• Trial Master File (TMF) Management

ATS Optimization Keywords

Hard Skills

• Clinical Study Protocol Compliance
• Site Qualification Visits
• Source Data Verification
• Adverse Event Review
• Data Quality Assurance
• Medical Device Trials
• Regulatory Reporting
• Document Management
• Data Trending Analysis
• SOP Maintenance

Soft Skills

• Verbal Communication
• Written Communication
• Attention to Detail
• Professionalism
• Team Collaboration

Industry Keywords

• Institutional Review Board (IRB)
• Code of Federal Regulations (CFR)
• Clinical Research
• Investigational Device
• Human Subject Protection

Tools & Technologies

• Microsoft Office Suite
• Electronic Trial Master File (eTMF)
• Clinical Monitoring Plan