Clinical Research Associate

8 mesi fa

Roma, Italia MSD A tempo pieno

The role of Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in a country.

Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.

**Responsibilities include, but are not limited to**:

- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
- Supports and/or leads audit/inspection activities as needed.

**Experience Requirements**:

- Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.

**Educational Requirements**:

- B.A./B.S. with strong emphasis in science and/or biology
- CORE Competency Expectations:

- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyse data/metrics and act appropriately.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Remote

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R285861

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