.¿Eres un CRA con experiencia y buscas un nuevo reto?
¡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 inSOP development, maintenance and training