Senior Research Regulatory Specialist (Hybrid)

Inside Higher Ed; Lexington (KY); Hybrid; USD 57,158 - 94,286; Full time

Job summary

A prominent educational institution seeks a Research Regulatory Specialist III (RRS III) in Lexington, KY. This role involves ensuring compliance with regulatory requirements for clinical research protocols, participating in site evaluations, and coaching junior staff. Candidates must possess a bachelor's degree and 4 years of related experience, including knowledge of FDA regulations. This position allows for a hybrid work arrangement, promoting flexibility in a supportive work environment.

Qualifications

• 4+ years of related experience, preferably in clinical research.
• Understanding of Good Clinical Practice (GCP) and FDA regulations required.

Responsibilities

• Responsible for obtaining and coordinating data to fulfill regulatory requirements.
• Maintain regulatory records according to FDA regulations.
• Participate in site evaluation and monitoring visits.

Skills

Comprehensive understanding of regulatory requirements for human subject research

Effective oral and written communication

Organization and attention to detail

Critical thinking and problem solving

Ability to teach/coach and lead teams

Education

Bachelors degree

Job description

A prominent educational institution seeks a Research Regulatory Specialist III (RRS III) in Lexington, KY. This role involves ensuring compliance with regulatory requirements for clinical research protocols, participating in site evaluations, and coaching junior staff. Candidates must possess a bachelor's degree and 4 years of related experience, including knowledge of FDA regulations. This position allows for a hybrid work arrangement, promoting flexibility in a supportive work environment.