Clinical Research Associate Milano

Clinical Research Associate
Milano
Lombardia, Milano

Clinical Research Associate**:

- Remote Eligible: Remote in Country- Onsite Location(s): Milan, MI, IT**Additional Locations**: Italy-Milan; Italy-Rome

**About The Role**:

The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO's mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with company's divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.

The CRA also provides support in start-up, enrollment, follow-up and closure of clinical trial activities.

Through coordination with Regulatory Affairs and the Contract & Budget team, and in collaboration with divisional and regional clinical teams, the CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are carried out consistent with service level agreements, legal and regulatory standards, and company's policies and procedures.

Specifically, these activities include Ethics Committee (EC) submissions and approvals, site Informed Consent Form (ICF) customizations and negotiations, essential regulatory document collection and other site start-up support activities, as applicable.

**In this role, you will be responsible for**:

- Source Verification: Conducting a comparison of data recorded on Case Report Forms against source documents, verifying Informed Consent Forms (ICFs) for accuracy and completeness, reviewing regulatory documents and device accountability records.

- Communications: Ensuring clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos and general correspondence.

Escalating serious issues as per company's escalation process when appropriate.

- Training: Ensuring all site personnel is appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations.

Monitoring and maintaining site personnel list, qualification and training records.

- Compliance: Ensuring compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc. )

and internal Standard Operating Procedures/Work Instructions, policies & procedures.

Ensuring any identified site non-compliance issues are addressed, clearly communicated, documented and escalated as required through monitoring visits, analyzing study metrics, and general study data overview.

Supporting internal quality audits and regulatory inspections, as required.

- Event Reporting: Ensuring that all reportable events are identified, clearly documented and reported per protocol and per applicable requirements and regulations.

- Collaboration: Participating in study-specific meetings, teleconferences and training.

Collaborating with cross-functional team members and study sites throughout all study phases.

Providing updates to leadership on site start-up activities, investigator readiness, regulatory submission and approval status.

- Documentation: Managing study contracts, request/collection of relevant (i. e.

regulatory documents) investigator/site documentation, review and approval of subset of documents in applicable database.

- Site start-up: Working independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.

Managing multiple sets of essential regulatory documents across several studies and division portfolios.

Partnering with clinical sites to support the negotiation and customization of ICFs.

Managing to achieve target EC timelines by assisting clinical research sites with the submission process and approval tracking.

- Study maintenance: Updating and maintaining study-specific startup trackers and site specific metrics in Clinical Trial Management Systems and maintaining site start-up documents in eTMFs (electronic Trial Master Files).

**What are we looking for in you**:

- Bachelor's Degree, or an equivalent combination of experience and education

- Fluency in Italian and English (written and spoken); a third foreign language spoken is considered a plus

- Research Coordinator or Clinical Research Associate experience - experience working with Clinical Trial Management and Electronic Data Capture systems is preferred

- Experience in Clinical Field Monitoring, within the Medical Device industry preferably

- Good organizational skills

- Strong communication & presentation skills

- Comfortable interacting with clinical research site personnel

- Ability to work in team

- Ability to multi-task: support several studies and/or personnel simultaneously

- Ability to work in a very fast-paced and dynamic environment

- Comfortable travelling up to 80% of time, mainly in Italy but not excluding short travels abroad

- Driving license

**What are we offering