Clinical Research Associate

5 mesi fa

Roma, Italia ICON plc A tempo pieno

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Integrity, Collaboration, Agility and Inclusion. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

**The Field CRA** is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines.

**Responsibilities**:

- Act as liaison between the in-house team, vendors, and multiple clinical sites.
- Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits.
- Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
- Assist with start-up activities, including essential document review and collection as requested.
- Perform Site Initiation Visits, Interim Monitoring Visits,Close Out visits as assigned.
- Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements.
- Monitor site compliance with study protocol and GCP.
- Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP.
- Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines.
- Perform drug accountability and ensure adequate drug supply.
- Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required.
- Assist study team as necessary in resolving lab queries and other issues.
- Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements.
- Ensure adequacy of clinical supplies to the site.
- Collect and review site essential documents and ensure site regulatory files are complete and accurate.
- Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals.
- Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance.
- Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.
- Track, report, and follow all action items to resolution.
- Maintain CTMS in a timely fashion, utilizing available reports and study tools.
- Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP.
- Assist data management as required.
- Provide co-monitoring support as requested or as necessary to develop additional skills

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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