ICON Strategic Solutions · 2 days ago

Early Development Oncology CRA II

Pennsylvania, United States

Full-time

Hybrid

Mid Level

2+ years exp

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Pharmaceutical Manufacturing

Actively Hiring

Hiring Manager

Kaitlyn Cogan

Insider Connection @ICON Strategic Solutions

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Responsibilities

To plan, execute and support clinical site management activities

To ensure the quality and integrity of the data collected in sponsored clinical trials in accordance with the approved protocol, SOPs, ICH/GCP and regulatory requirements.

To support the needs of internal and external clients or stakeholders.

Conduct clinical trial site visits including evaluation, initiation, monitoring and close out

Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems

Proactive site management including: Building and maintaining solid and professional relationships with site staff, Facilitating subject enrolment incorporating recruitment strategies and action plans at site level, Maintaining site audit/inspection readiness, Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks, Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan, Responding to site queries and escalating issues in accordance with processes and timelines, Conducting IP accountability and reconciliation, Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting), Maintenance of site study supplies

Contribute to sponsor goals

Promote operational and scientific excellence

Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.

Qualification

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Four-Year DegreeIndependent Monitoring