A global Clinical Research Organisation (CRO) is advertising a vacancy for a Senior CRA position. The company provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries by accelerating the global development of safe and effective medical therapies through its high-science and disciplined operating approach. Based in Turkey in a home-based capacity, this is an exciting opportunity to work for an international company and bolster a career in the clinical field.
- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
- Communicate with the medical site staff including coordinators and clinical research physicians and their site staff.
- Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
- Verify 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.
- Verify that the investigator is enrolling only eligible subjects.
- Review regulatory documents
- Investigate product/drug accountability and inventory.
- Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
- Assess the clinical research site's patient recruitment and retention success and offer suggestions for improvement.
- Complete monitoring reports and follow-up letters, which includes providing summaries of the significant find.
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.