An international contract research organisation (CRO) is recruiting for a SCRA/CRAII to join their Italian team. The company provides complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases and conducts studies which lead to marketing approval of significant medical advances. This is an exciting opportunity to work with a firm that has built a reputation on assuring the scientific objectivity and meticulous quality control that fulfils all regulatory requirements. The position will be with the company's Milan team, but in a home-based capacity.
- Monitors investigational drug studies in Phases I, II, III, IIIB, and IV, including:
- Source document review and comparison to CRF data
- CRF review/retrieval and data corrections
- Drug accountability
- Maintenance of on-site investigator files
- IRB documentation
- Local laboratory documentation
- Maintenance of investigational supplies
- Handling of safety and efficacy issues, including, but not limited to:
- Serious adverse event reports and adverse event trends
- Treatment failures
- Contributes to the selection of study investigators
- Conducts site contacts, including:
- Pre-study, initiation, monitoring visits
- Study completion visits
- Reviews consent process for each subject (Informed Consent Form and source documentation).
- Contribute to the training of newly-hired personnel, including Clinical Research Assistants.
- Participates in peer review of trainees upon manager's request.
Skills and Requirements:
- Bachelor's degree in biological sciences, advanced degree, MD preferred.
- Proven experience in immunology, Stem-cell and CAR-T clinical trials.
- Effective in writing contact reports, serious adverse events reports, status reports, and varied correspondence.
- Effective knowledge of the drug development process.
- Knowledgeable in the initiation, conduct, and completion of all phases of clinical trials.
- Ability to contribute to the site selection process (e.g., via an effective pre-study visit to a potential investigational site).
- Valid driver's license.
- 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 Stefania Bernardi at +44 203 078 9543 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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