Associate Clinical Research Associate

2 settimane fa

Roma, Italia MSD A tempo pieno

With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Performs remote and on-site monitoring & oversight activities
- 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.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Performs co-monitoring where appropriate.

**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**:R287872

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