Regulatory Specialist

• Job Title: Regulatory Affairs Specialist 1
• Employment Type: 1-year contract (Contract-to-Hire)
• Priority: High

The Clinical Research Regulatory Specialist serves as the primary oversight for research protocol documentation. You are responsible for ensuring all research activities are compliant, organized, and coordinated across multiple internal and external stakeholders.

• Complete and submit all documentation related to research protocols.
• Provide regulatory oversight for research involving physicians, clinicians, and various hospital departments.
• Ensure all research activities adhere to legal and ethical guidelines.

• Act as the central point of contact between:
• Clinical Research Staff
• Study Sponsors & CROs (Contract Research Organizations)
• IRBs (Institutional Review Boards)
• Internal Departments

• Organize and maintain complex regulatory records.
• Manage multiple shifting deadlines to ensure study continuity.

The hiring team is looking for a self-starter who can balance the technical nature of medical regulations with high-level administrative tasks.

• Communication: Exceptional written and verbal skills for interacting with medical professionals and agencies.
• Meticulousness: A high level of attention to detail to catch errors in sensitive legal/medical paperwork.
• Autonomy: The ability to work independently in a hybrid (remote/office) environment.
• Adaptability: Comfortable managing changing priorities in a fast-paced research setting.