Associate Clinical Research Associate

1 settimana fa


Roma, Lazio, Italia MSD A tempo pieno

Job Description:


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 onsite monitoring & oversight activities
  • Collects, reviews, and monitors required regulatory documentation for study startup, study maintenance and study closeout.
  • 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 comonitoring where appropriate.

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R266264

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