Job Description

EXPERIENCE REQUIREMENTS:

• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

EDUCATIONAL REQUIREMENTS:

• Preferred Scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field.
  Current Employees apply HERE
  Current Contingent Workers apply HERE

• 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.
• Gains an in-depth understanding of the study protocol and related procedures.
• 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.
• 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.