Associate Clinical Research Associate Lazio

Associate Clinical Research Associate
Roma
Lazio, Lazio

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.

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**Employee Status**:

Regular

**Relocation**:

No relocation

**VISA Sponsorship**:

**Travel Requirements**:

**Flexible Work Arrangements**:

Remote

**Shift**:

**Valid Driving License**:

**Hazardous Material(s)**:

**Requisition ID**:R287872