Regulatory Specialist/Affairs

The Kwality Group; Florida; On-site; USD 60,000 - 80,000; Full time

Job summary

A leading research organization in Florida is seeking a dedicated Regulatory Specialist/Affair to manage research processes in compliance with regulations. The ideal candidate will have a bachelor's degree with significant experience in clinical trials, including protocol management and regulatory compliance. This role entails drafting protocol documents and maintaining regulatory binders to ensure adherence to sponsor specifications. We welcome applicants with a master's degree and relevant experience in the clinical research field.

Qualifications

• 8 years experience in clinical trials, 2 years in clinical area.
• 4 years experience in clinical trials if holding a master's degree.

Responsibilities

• Deliver high-level research administration support.
• Manage research processes and obligations per regulations.
• Draft or edit protocol documents and submit for review.
• Maintain regulatory binders and delegation of authority logs.

Education

Bachelor's degree in a related field

Master's degree

Job description

8194 Natures Way unit 1, Lakewood Ranch, FL 34202, USA

Company

The Kwality Group, LLC

Job Description

We’re seeking a dedicated and compassionate Regulatory Specialist/Affair to join our team.

This individual delivers high-level research administration support and is responsible for managing research processes, activities and obligations in accordance with relevant legislation and regulations, policy, guidelines and applicable collective agreement(s) and standard operating procedures. He or she is typically responsible for drafting or editing the protocol document and submitting new protocols, protocol amendments, continuing reviews and safety reports to the appropriate IRB for review. They are responsible for maintaining regulatory binders in accordance with sponsor specifications and general industry standards. They often are the keepers of the delegation of authority log for key personnel involved in the study.

Minimum Qualifications:

A bachelor's degree in a related field and eight (8) years experience in clinical trials, two of which are in the clinical area.

OR a master's degree and four years of experience in clinical trials