Oncology CRA II: Partnering for Study Excellence

BioSpace

Washington (District of Columbia)

On-site

USD 90,000 - 120,000

Full time

2 days ago
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Job summary

AbbVie is seeking a clinical research professional to advance our pipeline by delivering excellence in clinical research and leveraging advanced capabilities to drive performance. You will partner with investigators and site staff to position AbbVie as the choice for clinical trials and focus on site engagement, data integrity, and patient safety.

Work involves monitoring activities, training site staff, and ensuring protocol adherence, regulatory compliance, and high-quality data across

Qualifications

  • Minimum of 1 year of clinically related experience, including clinical research monitoring of investigational drug or device trials.
  • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
  • Strong cross-functional collaboration skills among internal and external stakeholders.
  • Strong planning and organizational skills in a dynamic environment with competing projects and deadlines.

Responsibilities

  • Primary point of contact for the investigative site and ensure effective engagements.
  • Aligns, trains and motivates site staff and principal investigator on trial goals, protocol and patient treatment principles.
  • Monitors site activities with compliance to protocol, good clinical practices and quality standards.
  • Gather local/site insights and utilize engagement tools to report progress and measure impact.
  • Connect protocol, scientific principles and trial requirements to day-to-day execution and ensure patient recruitment and protocol compliance.
  • Mentor and train less experienced CRAs and participate in global/local initiatives.
  • Manage risk assessment and monitor site performance with Central Monitoring team.
  • Identify, evaluate and recommend new investigators/sites to support planned studies.
  • Ensure quality of data and timely reporting for safety events and audit readiness.

Skills

Clinical monitoring
GCP familiarity
Cross-functional collaboration

Education

Health-related tertiary qualification

Job description

AbbVie is seeking a clinical research professional to advance our pipeline by delivering excellence in clinical research and leveraging advanced capabilities to drive performance. You will partner with investigators and site staff to position AbbVie as the choice for clinical trials and focus on site engagement, data integrity, and patient safety.

Work involves monitoring activities, training site staff, and ensuring protocol adherence, regulatory compliance, and high-quality data across

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