Covance Clin Res Assoc II in Seoul, South Korea

Job Overview

Responsibilities include, but are not limited to:

  • 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.

  • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

  • Participates & provides inputs on site selection and validation activities.

  • Performs remote and on-site monitoring & oversight activities using various tools to ensure:

  • Data generated at site are complete, accurate and unbiased

  • 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.

  • 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.

  • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA manager, CRM, and RCPM.

  • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.

  • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.

  • Supports and/or leads audit/inspection activities as needed

  • Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities

Education/Qualifications

B.A./B.S. with strong emphasis in science and/or biology

Experience

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

Job Number 2018-23640

Job Category Clinical Research Associate

Position Type Full-Time

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