Korte omschrijvingVoor mijn klant in het zuidwesten van Nederland ben ik op zoek naar een CRA met minimaal 1 jaar zelfstandige monitorervaring. De positie kan zowel officebased als homebased worden ingevuld.
BedrijfsprofielMijn klant is een internationale midsized CRO waar een goede sfeer en teamspirit hoog in het vaandel staan. Ze hebben veel uitdagende klinische studies binnen diverse therapeutische indicatiegebieden zoals oncologie, rare diseases, cardiologie en medical devices.
Functie omschrijvingAs a CRA, you will specifically be responsible for the following:
•Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
•Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
•Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
•Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
•Verification that the investigator is enrolling only eligible subjects;
•Regulatory document review;
•Medical device and/or investigational product/drug accountability and inventory;
•Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
•Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
•Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Functie eisen•Minimum of a bachelor’s degree; Health or life science related field preferred;
•Minimum of 2 years independent CRA/monitoring experience
•Willing to travel approximately 60-80% nationally;
•Master the Dutch and English language on a professional level;
•Familiarity with Microsoft® Office; and
•Strong communication and presentation skills a plus.

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