Clinical Research Associate

Meditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access. Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators. Our successful track record supporting medical device and biotechnology companies 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. Meditrial, as a recognized leader in the medtech field participates in the development of global standards, policies and regulations. We have the ability to transcend the current landscape with “smart” technology enabled data collection tools and insights that are being regulated by the medical device “rule book”.

It is our belief that the future of traditional therapeutics and the treatment paradigm will include medical device regulation
- Some examples to name a few: Drug Delivery Systems, Companion Diagnostics, Digital Apps, Wearables, AI enabled pills, Precision dosing tools, Clinical assessment technology etc.

With over a decade of history, operating throughout Europe to manage trials sponsored by global companies, we offer highest level expertise across multiple therapeutic areas including notable depth in cardiovascular and respiratory, orthopedics, oncology, CNS, infectious disease, endocrinology, diabetes, among other indications. We are passionate about our mission to support the innovation and development of better therapies in healthcare 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.

**Clinical Research Associate - Rome**:
Meditrial is looking for a certified clinical research associate (CRA) experienced in clinical trial monitoring, EDC systems, Digital Health solutions and Data analysis. The resource will participate in the preparation and execution of Phase I-IV clinical trials, oversee the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. He/she will monitor clinical trials in accordance with Good Clinical Practices and procedures set forth by Meditrial and sponsors. He/she will work closely with the Clinical Project Manager to ensure all monitoring activities are conducted according to study requirements.

The resource may be involved in Trial management activities in close collaboration with the CTAs and under the supervision of the Clinical Project Manager.

The CRA will be available to travel for monitoring activities.

**Responsibilities**:
Conducting monitoring from SIV to COV and follow-up, investigator training
Reviewing study case report forms (CRFs) completed by the investigative sites, and verifying entries by validating accurate source documentation to support CRF entries
Documenting site visits and issues in reports and follow-up letters to the site
Facilitating effective communications among investigative sites, the client and Meditrial
Identifying potential investigators in collaboration with the client
Responding to company, client and national regulatory requirements/audits
Contributing to the preparation of local forms and documents necessary for Study submission
Contributing to the project team by assisting in project communications

**Qualifications**:
Over 6 years experience in monitoring for CROs
Higher or specialized secondary education degree in natural sciences
CRA Certification with monitoring visits are required
Familiar with electronic CRF and CTMS systems
**Industry background**: CRO/outsourced services, Pharmaceuticals, Biotechnology, Medical Device
Recent experience in medical device clinical trials
Fluency in English and Italian language