Responsibilities:
– Coordinating clinical research studies and maintaining a safe study environment according to health and safety guidelines under the direction and delegation of the Principal Investigator
– Ensuring the well-being of patients, addressing their concerns while ensuring the highest quality
– Blood sampling, ECG, vital signs
– Caring for patients and supporting staff with administrative tasks
– Maintaining study protocols, case report forms (CRFs), electronic data capture systems (EDC), and other study documents up to date
– Planning and coordinating logistical activities for study procedures according to the study protocol
– Conducting clinical preparations for the study, including labeling sample collection tubes and containers, inventorying required materials, and setting up or troubleshooting equipment and/or the study
– Data entry, data quality review, and responding to queries
– Supporting patient enrollment in the study through recruitment, screening, and briefing according to the study protocol
– Collecting, recording, and reporting clinical data and findings appropriately in CRFs and collaborating with the investigator on study-related adverse events and serious adverse events according to the study protocol
– Coordinating with the study monitor on study issues and effectively responding to questions posed by the monitor
Qualifications:
– At least two years of relevant experience; or an equivalent combination of medical education, training, and experience
– Experience with blood sampling, ECG, and vital signs
– Knowledge of clinical studies combined with solid knowledge of department-, protocol-, and study-specific workflows, informed consents, and study plans
– Strong IT skills, proficient in MS Windows and Office applications such as Access, Outlook, Excel, and Word
– Excellent interpersonal skills with the ability to build and maintain effective working relationships
– Very good German language skills, both spoken and written