Job Title: Regulatory Specialist
Location: Remote (East Coast Hours)
Type: Contract

Requirements:

• Bachelors Degree preferred with 2 years of experience in regulatory
• Knowledge of Clinical Trial procedures, ICH-GCP guidelines
• Proficient in Microsoft Excel, Word and PowerPoint
• Experience with EDC (electronic data capture) system
• Experience with the following systems is a plus:
  • Medidata RAVE
  • IBM Clinical Development
  • Oracle Inform

Responsibilities:

• Supports clinical research team in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
• Manages identified issues and provides feedback to leadership regarding resolution.
• Disseminates information and participates in training.
• Provides direction and feedback to research team to ensure awareness of business practices and quality standards.
• Manages new submissions and continuing review activities.
• Reviews initial submissions to determine review category and action to be taken.
• Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
• Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.
• Reviews regulatory documentation involving clinical trials to ensure compliance with Institutional Review Board (IRB) policies and procedures and regulations and guidelines.
• Compares reported data with original source documents.
• Verifies protocol compliance (i.e., eligibility criteria and informed consent)
• Electronic data capture completion (EDC).
• Gather data from multiple source documents and enter into electronic database system.
• Address data queries and make data-related corrections as needed.
• May have access to sensitive patient information, maintaining the integrity of the records is a very important responsibility.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.