Ref #: 25881

Employment type: Permanent - Full-Time

Location: US - Pennsylvania

Posted: 06-Jan-2021

Description

Roles & Responsibilities

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

Qualifications:
• BA/BS/BSc in the sciences or nursing equivalent
• A trained CRA with on-site monitoring experience
• Comprehensive knowledge and understanding of ICH-GCP
• Fluent oral (face to face and telephone) and written English language skills
• Able and willing to travel up to 60% of the time or as per local requirements
• Possession of a full driver’s license
• Able and willing to work from a designated and appropriate home office as per local requirements
• Experience/working knowledge of the oncology disease area (preferred)
• Experience of Centralized/Risk Based/Targeted monitoring (preferred)
• Experience of working within a metric based environment (preferred)

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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