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 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 willingness to travel within Spain and Portugal.
Responsibilities:
1. Monitor clinical research in accordance with the protocol, SOPs, applicable laws, and ICH-GCP guidelines, including visit report compilation and follow-up within set timelines.
2. Perform feasibility, site selection, initiation, monitoring, and close-out visits following contracted scope of work, using good clinical practices, applicable laws, regulations, SOPs, and Work Instructions.
3. Conduct feasibility assessments, Medical Ethics Committee activities, and health authority interactions; may be involved in contract negotiations with investigators or hospitals.
4. Evaluate the quality and integrity of study site practices related to protocol conduct and adherence to regulations.
5. Escalate quality issues to the Clinical Team Lead and/or Line Manager.
6. Manage the progress of assigned studies by tracking regulatory submissions, approvals, recruitment, CRF completion, and data queries.
7. Train investigators and site staff on protocol implementation, CRF, and study procedures; establish communication to manage ongoing project expectations and issues.
8. Assist in organizing CRA/Investigator meetings, if applicable.
9. Develop and maintain effective relationships with site staff.
10. Create and maintain documentation related to site management, monitoring visits, and study conduct, including reports, follow-up letters, and document filing.
11. Ensure proper reporting and follow-up of adverse events and reactions.
12. Support investigators during inspections and audits by healthcare authorities.
13. Participate in SOP development, maintenance, and training.
14. Qualifications:
* Higher education in a (bio)medical field preferred.
* At least one year of relevant CRA experience in clinical research.
* Up-to-date knowledge of ICH-GCP guidelines, clinical trial regulations, and legislation.
* Effective communication skills in English and Spanish.
* Proactive with strong negotiation skills.
* Ability to work independently and within a team matrix organization.
* Willingness to travel irregularly.
* Practical knowledge of Microsoft Office.
* Driver's License.
What We Offer:
An open culture in an innovative, dynamic environment with inspiring colleagues and good working conditions.
Room for creativity, initiative, and influence on our work processes.
Interested?
Send your CV and motivation to us. For further questions, contact Ellen Hunink (HR Business Partner, 06-2116 2980) or Floor Hobbelink (Manager Clinical Monitoring, 06-46435726).
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