Clinical Trials Regulatory Specialist
2 months ago
Overview:
The Commonwealth of Virginia is seeking a dedicated and detail-oriented individual to join our Clinical Research Office as a Clinical Trials Regulatory Specialist. This role is essential in ensuring the smooth operation and compliance of clinical trials within our esteemed School of Medicine.
About Us:
The School of Medicine is a leading academic institution known for its commitment to advancing medical research and education. We offer a comprehensive benefits package that includes competitive health benefits, paid leave, retirement planning, and professional development opportunities.
Key Responsibilities:
- Regulatory Oversight and Study Initiation (60%):
- Manage regulatory documentation for clinical trials.
- Prepare and submit IRB protocols and documents.
- Ensure compliance with federal regulations and guidelines.
- Act as a liaison between regulatory bodies and internal teams. - Support for Research Teams (20%):
- Provide guidance on regulatory compliance to investigators.
- Assist in site selection and study planning activities.
- Maintain up-to-date task lists for study teams throughout the activation process. - Standard Operating Procedures Development (10%):
- Create and implement standard operating procedures to ensure regulatory compliance.
- Lead the development of best practice guidelines for clinical research coordination. - Collaboration and Customer Service (10%):
- Foster ongoing communication with various departments and stakeholders.
- Provide expert advice on regulatory matters and support clinical research operations.
Qualifications:
- Bachelor's degree or equivalent experience.
- Minimum of 2 years of experience in clinical research coordination.
- Knowledge of federal regulations and GCP/ICH guidelines.
- Strong communication skills and attention to detail.
Preferred Qualifications:
- Experience in multi-site study regulatory management.
- Certification in clinical research or related fields.
Work Environment:
This position offers a hybrid work model, allowing for both remote and in-office work as needed.
The Commonwealth of Virginia is an equal opportunity employer, committed to fostering a diverse and inclusive workplace.
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