Site Management Assistant Lazio

Site Management Assistant
Roma
Lazio, Lazio

Duties and Responsibilities**:

- ** Ensure compliance with Labcorp SOPs, Project-specific Controlled Documents, FDA and ICH guidelines, GCPs, and GPPs for clinical conduct in all aspects of daily work including adherence to Project Plans, Data Management Plans, Site Management Plan, Monitoring Conventions, etc.

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- ** Assist with the facilitation of site evaluation and recruitment including, collection and review and close out of required critical documents from sites (including submissions and notifications to Institutional Review Boards or Ethics Committees (where applicable)) by c**reating, updating, tracking, and maintaining study-specific trial management files, tools, and systems.

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- ** Support investigators in fulfilling their obligations with regard to submission according to applicable local, regulatory, and IRB/IEC requirements.

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- ** Manage study sites to ensure adherence to study design.

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- ** Maintain timely documentation of site contacts in defined project system.

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- ** Act as primary point of contact for assigned study sites and retain primary responsibility for the resolution of all site issues.

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- ** Assist with administrative duties including preparation of status reports, payments to sites and participation in regular project team meetings including preparation and distribution of meeting minutes.

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- ** Facilitate communications with vendors and assist with the management of study supplies.

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- ** Assist with the review study data in accordance with Monitoring Plan, Site Management Plan, Data Management Plans and applicable (SOPs, etc) to identify data trends, data inconsistencies, and erroneous, missing, incomplete, or implausible data through the aggregate review of study data by patient, site, and/or project.

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- ** Ensure accurate and expeditious safety reporting in accordance to federal guidelines and sponsor and program requirements.

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- ** General Monitoring Responsibilities - Centralized**:

- ** Assist in the initiation, monitoring and close out of Investigator sites via phone including review of Case Report Forms.

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- **Review site information and communicate with sites to resolve data discrepancies.

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- ** Perform other duties as assigned by management.

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Experience Required

**1. It is focused on the **Late Phase** arena.

This is a very regulated environment** **and we need you to have hands-on working experience in **Phase IIIB**, **Phase IV **and** **Non-Interventional / NIS** studies.

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**2. This **job** would suit experienced **CRAs** who want to stop travelling and current **(sr) IHCRAs** working at the pharmaceutical, biotech or CRO environments.

In lieu of that experience we are open to consider experienced **study coordinators** and **study nurses**. **:

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**3.

We can only consider profiles who speak **3 European languages** (English is mandatory, a local language plus a third one like German, Spanish, French, Italian, Polish )**:

**Labcorp is proud to be an Equal Opportunity Employer**:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply.

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