Regulatory Specialist
Kforce Inc

Job Info

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RESPONSIBILITIES:

Kforce has a client in Pasadena, CA that is seeking a Regulatory Specialist.Summary:The Regulatory Specialist position provides regulatory document support to the company's principal investigator and research sites conducting multiple FDA-regulated or other clinical trials. The Regulatory Specialist provides operational support for regulatory compliance. This position works in consultation with the principal investigator, sub-investigators and teams members. The Regulatory Specialist Is also responsible for assisting in protecting the health, safety, and welfare of research participants. In this role, the candidate is a non-licensed person which must adhere to the position's scope of practice.

REQUIREMENTS:

• Must be proficient in word-processing, spreadsheet, and database software
• Demonstrate excellent written, verbal, and interpersonal communication skills
• Ability to read and comprehend complex study documents and summarize key components in a succinct manner
• Attention to detail and accuracy.
• Ability to manage multiple tasks with strict timelines.
• Demonstrate prioritization and organizational skills.
• Ability to address issues with problem solving skills
• Ability to work effectively on cross-functional teams
• Basic knowledge of the principles, methods and procedures of basic medical and/or clinical research processes
• Basic knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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