An international pharmaceutical company is seeking to recruit a CRA II to their Turkish team on a home-based capacity. The company specialises in end-to-end clinical and commercial solution organisation that focuses on biopharmaceutical acceleration. This is an exciting opportunity to work with a dynamic and innovative organisation that meets the needs of emerging and large global biopharmaceutical companies.
- Conducting qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
- Communicating 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.
- Verifying Medical record and research source documentation 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.
- Verifying that the investigator is enrolling only eligible subjects.
- Reviewing Regulatory documents.
- Investigating product/drug accountability and inventory.
- Verifying and reviewing 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.
- Completing monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Skills and Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarani at +44 203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.