Summary:

Clinical Trials & Surveys Corp. (C-TASC), an independent research organization seeks a Quality Assurance/Regulatory Professional with experience interpreting and applying regulations related to the conduct of clinical research.

Responsibilities:

• Oversee creation of Standard Operating Procedures, Work Instructions, and other controlled documents.
• Prepare and review regulatory documents including INDs, protocols, and informed consent forms.
• Provide regulatory guidance to C-TASC senior staff and the Institutional Review Board.
• Create, provide, and track training for all C-TASC staff.
• Conduct internal and vendor audits of SOPs as needed.
• Contribute to the development of validation and test plans of the C-TASC IT systems.
• Contribute to project work as needed.

Qualifications:

1. Bachelors degree in a scientific field
2. Certification in regulatory, quality or clinical research is preferred.
3. A minimum of seven years experience in regulatory and/or quality assurance.
4. Experience with Part 11 compliance/computer system validation is highly desirable.