Clinical Research Associate II — Driving Site Excellence

BioSpace

Virginia

On-site

USD 70,000 - 100,000

Full time

29 hours ago
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Job summary

AbbVie seeks a Clinical Research professional to advance its clinical programs by engaging with investigative sites and driving data integrity and protocol compliance. You will monitor site performance, train staff, and collaborate across functions to enhance patient safety and trial success.

The role emphasizes risk-based monitoring, regulatory knowledge, and mentorship of junior CRAs, in a fast-paced environment focused on quality and compliance.

Qualifications

  • Minimum 1 year of clinically related experience, with 6 months in clinical research monitoring.
  • Advanced knowledge of local regulatory and ICH/GCP guidelines.
  • Strong cross-functional collaboration and communication skills.
  • Ability to train and mentor less experienced CRAs.

Responsibilities

  • Primary point of contact for investigative sites and site staff.
  • Aligns and trains site staff on trial goals, protocol, and patient treatment principles.
  • Performs site evaluation, monitoring, and training with compliance to protocol and SOPs.
  • Mentors CRAs and may participate in task forces or initiatives.
  • Monitors risk and ensures corrective actions to protect patient safety and data quality.

Skills

Clinical monitoring
Regulatory knowledge
ICH/GCP
Cross-functional collaboration
Risk-based monitoring
Data integrity

Education

Tertiary health qualification

Tools

CRM tools

Job description

AbbVie seeks a Clinical Research professional to advance its clinical programs by engaging with investigative sites and driving data integrity and protocol compliance. You will monitor site performance, train staff, and collaborate across functions to enhance patient safety and trial success.

The role emphasizes risk-based monitoring, regulatory knowledge, and mentorship of junior CRAs, in a fast-paced environment focused on quality and compliance.

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