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We see human behind every number
**Clinical Research Associate II
**Location: Italy (home-based)
On behalf of our partner, one of the global leaders in clinical research, we are currently recruiting for a Clinical Research Associate II in Italy to work for a global biotechnology company.
As a CRA II in Italy you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally.
**Detailed Job Duties and Responsibilities
- Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
- Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
- Balancing sponsor generated queries
- Taking responsibility for study cost efficiency
- Preparation and review of study documentation and feasibility studies for new proposals
- Potential to assist in training and mentoring fellow CRAs
**Education / Qualifications / Skills Requirements
- 18 months+ of independent monitoring experience in phase I-III trials as a Certified CRA
- College degree in medicine, science, or equivalent
- Previous independent monitoring experience in medium-sized studies, including study start-up and close-out
- Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
- Excellent written and verbal communication in English
- Ability to work to tight deadlines
- Availability to travel least 60% of the time (international and domestic -fly and drive)
- Experience in Oncology is mandatory
**Benefits**:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
- Global Employee Assistance Program
- Life assurance
- Country-specific flexible benefits, including options like gym membership discounts, childcare vouchers, and more.
KCR is a clinical development solutions provider creating value for emerging biotechnology organizations.
**Our Privacy Policy
Your data will be processed in accordance with KCR Group Privacy Policy. For more details click here: Privacy Policy.
You may withdraw any consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.
Your personal data will be shared with KCR and/or KCR affiliate that you are pursuing, and that company will be considered a separate data controller of your personal data. A full list of KCR affiliates is available at: Privacy Policy.
KCR is an equal opportunity employer. In line with our motto, 'We see human behind every number, ' KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.
We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.
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