Overview

The Senior Clinical Research Associate proactively participates in conducting clinical investigations with medical devices primarily in Germany and UK and possibly also in other European countries e.g., Austria and Switzerland. The Senior Clinical Research Associate is expected to work detail-oriented with a proven “can do” attitude, and in an international environment.

Key Skills and Qualification

• In coordination with the study team members, oversees the progress of a clinical study ensuring that it is conducted, documented, and reported in accordance with the clinical investigation plan (CIP), Cook procedures, national requirements, and international regulatory guidelines.
• Supports implementation of assigned medical device studies in accordance with internal and external regional requirements. Tasks include amongst others the acquisition of approval from Ethics Committees, Case Report Form (CRF) review, and all aspects of monitoring.
• Schedules and conducts site assessment visits and presents feasibility result to the study team.
• Independently and with only minimal supervision, trains and monitors (on site and remote) clinical sites in accordance with the training plan and monitoring plan by preparing and conducting Site Initiation Visits, Periodic Site Visits, and Close Out Visits. Generates detailed and timely reports and follow-up communication for each visit.
• Maintains close contact with clinical study sites and communicates study requirements to investigators and site personnel.

Responsibility

• In coordination with the study team members, oversees the progress of a clinical study ensuring that it is conducted, documented, and reported in accordance with the clinical investigation plan (CIP), Cook procedures, national requirements, and international regulatory guidelines.
• Supports implementation of assigned medical device studies in accordance with internal and external regional requirements. Tasks include amongst others the acquisition of approval from Ethics Committees, Case Report Form (CRF) review, and all aspects of monitoring.
• Schedules and conducts site assessment visits and presents feasibility result to the study team.
• Independently and with only minimal supervision, trains and monitors (on site and remote) clinical sites in accordance with the training plan and monitoring plan by preparing and conducting Site Initiation Visits, Periodic Site Visits, and Close Out Visits. Generates detailed and timely reports and follow-up communication for each visit.
• Maintains close contact with clinical study sites and communicates study requirements to investigators and site personnel.