Clinical Research Associate
hace 4 semanas
Nos gustaría ponernos en contacto contigo Do you like to coordinate and monitor (inter)national, multicentre clinical trials in order to assure the quality of the clinical data?
Then this could be the opportunity to develop your career at our Scientific CRO. We are actively looking for a talented and proactive Clinical Research Associate with strong communication and negotiation skills and with willingness to travel within Spain and Portugal.
Tasks and Responsibilities of the Clinical Research Associate- Monitors clinical research in accordance with the protocol, SOPs, applicable laws and ICH-GCP guidelines, including visit report compilation and follow-up within the set timelines.
- Performs feasibility, site selection, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices, applicable laws and regulations SOPs and Work Instruction.
- Performs Feasibility, Medical Ethics Committee Health authority activity and can be involved in contract negotiation activities with investigator or hospital.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalates quality issues to Clinical Team Lead and / or Line manager.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
- Train investigators and site staff (including laboratory, pharmacy and other staff involved) in the correct implementation of the protocol, the CRF and study-specific procedures and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Assists in organizing CRA / Investigator meetings, if applicable.
- Develops and maintains an effective working relationship with site staff.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action items by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
- Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions.
- Supports the investigator during inspections by healthcare authorities or audits.
- Is involved in SOP development, maintenance and training.
- Higher level of education preferably in an (bio)medical field.
- At least one year of relevant experience, as a CRA, in clinical research.
- Up-to-date knowledge of ICH-GCP guidelines, clinical trial regulations and legislation.
- Effective oral and written communication skills in English and Spanish.
- Proactive, strong communication and negotiation skills.
- Ability to work independently as well as in a team matrix organization.
- Ability to travel on an irregular basis.
- Practical knowledge of Microsoft Office.
- Driver's License.
An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions.
An environment where you have room to be creative, take initiative and have direct influence on the way we work.
How to ApplyAre you interested?
Send your CV and motivation to
- If you have further questions, you can contact Ellen Hunink (HR Business Partner, 06-2116 2980) or Floor Hobbelink (Manager Clinical Monitoring 06-46435726).
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