Position: Clinical Research Associate

3 giorni fa

Provincia di Roma Lazio, Italia Meditrial Europe Ltd. A tempo pieno

Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.

Since 2008, Meditrial delivers unparalleled outcomes for innovators. Our successful track record supporting the lifescience industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden. Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value. We have the ability to transcend the current landscape with “smart” technology enabled data collection tools and insights.

Meditrial offers highest level expertise across multiple therapeutic areas. We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards. Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

**Position: Clinical Research Associate**:
**Industry**: Lifescience Industry: Pharma, Medtech, Digital Health

**Employment Type**: Full-time

**Job Functions**: Clinical Affairs

**Location**: Meditrial, Via Po 9 Rome, Italy

**Workplace**: Office-based / availability to travel

Meditrial is looking for an experienced Clinical Research Associate. The position offers opportunities for growth in the field of drug and medical device trials while also impacting and lessening patient's burden. We are looking for a practical-minded profile ready for new challenges in the medtech and pharma space.

**Responsibilities**:

- Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
- Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
- Verify 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;
- 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;
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Skillset & Qualifications
- Education: Bachelor’s degree, Master is a plus;
- CRA Certification
- Fluent Italian and English
- Strong communication and social skills
- Minimum 2 years experience in life science field and Quality Management;
- Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, Ms Power Point);

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