Job Title: Field Clinical Research Associate – Heart Failure
Industry: Medical Devices
Salary: ca. €50,000 + Bonus
You will be working as a Field Clinical Research Associate in a company which have a unique and innovative implantable device for heart failure patients. They have 10 years clinical data behind them, which is forever growing. My Client are rapidly growing which has allowed them to invest in state of the art Headquarters based in Stuttgart. Currently, they are working towards their FDA approval, which is one of their main goals for the near future.
As a Field Clinical Research Associate, you will be responsible for…
- Conduct Monitoring Visits (Site Feasibility Visit, Site Initiation Visit, Interim Monitoring Visit, site close-out Visit) including to monitor documents, status and proper study binders at the site. Handle and communicate immediate issues to the attention of the Clinical Operations Manager Europe for timely resolution.
- Support and guide the hospital study nurse/coordinator in the collection and handling of all test data and test results in accordance with the study designs. Assure availability of source documents and recording of data in the study database by the site.
- Supervise and support the coordination of the patient follow up visits and tests at the different test sites/hospitals, where possible.
- Train, support, supervise and guide the hospital staff/study nurse/coordinator in the execution, collection and handling of all test data, CPET- tests/procedure in accordance with the study design.
- Work with the Clinical Operations Manager Europe to ensure the success of CPET and ensure that the relevant site personnel send CPET and other tests results to interpretation by core laboratories.
- Support preparing of study related documents
- Support the data collection
To apply for the role of Field Clinical Research Associate you will have…
- Trained in Good Clinical Practice (GCP) with certification
- Experienced in in-field conduct of FDA-related studies in Europe
- Field experience (preferably of more than 3 years) in activities related to communication with and submission of protocols to ethical committees and competent authorities, site initiation and training, assistance in data collection, monitoring study progress, documentation & CRFs, SAE reporting, and production of study related reports
- Fluent German and English (verbal and written professional communication)
- Experienced in in-hospital work environment, interaction with hospital staff and familiarity with typical hospital processes.
- Mobile (very important): available for frequent travels among sites in the region and throughout Germany.
For more information about the role call me Olivia Anton for a confidential chat on 0203 8000 511 or email me on Olivia@projectusconsulting.com today.
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