The Clinical Research Associate supports the management of clinical projects to achieve agreed milestones and budgetary targets while maintaining conformance to appropriate standards and regulations (EU and FDA).
Key Results Area:
• DELIVERY OF CLINICAL PROGRAMME IN LINE WITH R&D, REGULATORY AND COMMERCIAL OBJECTIVES.
• ASSISTANCE AND SUPPORT IN CERTIFICATION AND REGULATORY SUBMISSION OF EXISTING AND NEW PRODUCTS THROUGH THE CLINICAL EVALUATION.
• To conduct and support the day to day management of activities associated with the execution and monitoring of clinical investigations.
Job Tasks and Responsibilities:
• Participate in Marketing and R&D project team meetings as needed so that clinical activities support product development projects
• To undertake a clinical evaluation to assess and analyze the clinical data to verify the clinical safety and performance of the AMS medical devices;
• Support the Clinical Research Team with managing all aspects of trial development and initiation such as protocol, case report form, site materials development, contract negotiation, collection and filing of essential documents and site initiation;
• Coordinate Institutional Review Boards, Ethics Committees approvals, amendments, reporting and closure;
• Support and track subjects subject enrolment, follow up, and adherence to protocol follow up
• Maintains the Sponsor’s Trial Master File,
• May perform onsite monitoring activities.
• Supports data collection, assessment, reporting and assist with writing and editing of documents.
• Ensures compliance with all applicable regulatory standards related to clinical research, clinical trials, interactions with physicians, clinical policies, guidelines and regulations.
• Provides clinical input for the product development process including regulatory submissions, marketing material, and risk documentation.
The ideal candidate will have:
• Bachelor Degree in Natural or Health Science (PA or RN),
• CCRP (Certified Clinical Research Professional), CCRA (Certified Clinical Research Associate),
• 0-2 years of previous relevant clinical experience with medical devices
• Experience of biological medical devices and surgical experience would be advantageous,
• Knowledge of FDA regulations and guidance governing clinical studies including 21 CFR 812, 50, and 56, ICH GCP, and HIPAA,
• Excellent written and verbal communication skills,
• German Speaker would be an advantage,
• Ability to travel 10-20%.