A global Clinical Research Organisation (CRO) is currently recruiting for a 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 the company's German office, this is an exciting opportunity to work for an international company and bolster a career in the clinical field.
This is a unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with a medical and/or health/life science interest and background - who wants to explore the research field, travel the UK, and be part of a team bringing pharmaceuticals to market - this could be the right opportunity for you.
- 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.
- Conducting 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.
- Communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
- Verifying that the investigator is enrolling only eligible subjects.
- Conducting regulatory document review.
- Conducting 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.
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 0203 854 2629 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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