CRA II/Clinical Research Monitor II - Munich /home based
ProClinical is partnering with a global Clinical Research Organisation (CRO) to advertise a vacancy for a CRA II/Clinical Research Monitor 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 Munich office in a remote 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;
- 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.
Skills and Requirements:
- Must have a minimum of a university degree in a health or life science related field;
- 2 years of previous experience as a CRA;
- Approximately 60-80% travel in Germany, Austria and Switzerland;
- 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 Theodora Savlovschi-Wicks at +44 203 752 0314 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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