Clinical Research Associate
A tight knit Clinical Research firm (CRO) are currently advertising a vacancy for a Senior Clinical Research Associate(CRA). The organisation specialises in the regulation and clinical development of new medical technologies. This is the ideal opportunity for a candidate who's looking to positively contribute to the development of medicine.
- The successful candidate must have full knowledge of European regulations relating to clinical research on Medical Devices
- Is aware of the specificities for the clinical studies which he/she is responsible.
- Remaining compliant with the specific provisions of the protocol and agreements
- Ability to coordinates with team of CRAs, project Managers, the investigators and the clinical study sponsor.
- Under the responsibility of the Project Manager or Director of Clinical Operations, he/she ensures that clinical trials are properly followed through, that the scientific data collected during the clinical study is reliable.
- The Senior CRA will supervise and organize the work of Junior and intermediate CRA assigned, coordinate the project with other departments involved (Regulatory Affairs, Biometry).
- Assists the Project Manager to prepare and follow up submissions to the Ethics Committee and the relevant
- Makes sure that applicable Standard Operating Procedures (SOPs) are implemented and that all relevant information about clinical trials are reported to the correct department.
- Prepares the appropriate monitoring tools according to applicable SOPs, based on the protocol and the CRF.
Skills and Requirements
- Graduated with a scientific specific degree (medical, paramedical, biomedical engineering or other)
- More than 3 years' experience as a CRA, including experience abroad
- Experience in CRO or the MD industry
- Knowledge of the MD environment (MDD, AIMD, EN ISO 14155)
- Fluent English Other desired language(s): German, Italian, Spanish
- Great organizational skills, interpersonal skill and proactiveness
- Comfortable with 75% of working time travelling
- Leadership skills
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.