Regulatory Specialist I, Gerontology

Wake Forest University Health Sciences

Unknown, ,
Base: $26.55 - $39.85; bonus/equity: not specified...
Hybrid
Clinical trial regulatory support
Fda-regulated clinical trials
Irb standard operating procedures
Performs administrative and coordinative work directed toward the design, implementation, evaluation and review of assigned clinical trials by working closely with Principal Investigators (PI) and other Clinical Protocol and Data Management (CPDM) staff members

Job Summary

  • Performs administrative and coordinative work directed toward the design, implementation, evaluation and review of assigned clinical trials by working closely with Principal Investigators (PI) and other Clinical Protocol and Data Management (CPDM) staff members.
  • Provides operational support for regulatory compliance to research sites conducting multiple FDA-regulated or other clinical trials.
  • Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more.

Matching Summary

Performs administrative and coordinative work directed toward the design, implementation, evaluation and review of assigned clinical trials by working closely with Principal Investigators (PI) and other Clinical Protocol and Data Management (CPDM) staff members.

Salary

Base: $26.55 - $39.85; Bonus/Equity: Not specified; Benefits: Yes

Skills & Requirements

Must-have

  • Clinical trial regulatory support
  • FDA-regulated clinical trials
  • IRB Standard Operating Procedures
  • Good Clinical Practice adherence
  • Maintain regulatory files
  • OnCore (WISER) proficiency

Nice-to-have

  • Interpersonal communication skills
  • Attention to detail and accuracy
  • Prioritization and organizational skills
  • Manage multiple tasks
  • Sensitivity to intercultural relations
  • High level of integrity

Key Requirements

  • Bachelor's degree in Education, Public Health, Basic Science, or relevant clinical discipline
  • Two years of research experience
  • Coordinating regulatory and/or data management activities
  • Master's degree preferred
  • Experience in budget and financial tracking preferred
  • SOCRA or ACRP Certification preferred
  • CITI certification for Human Subject Research required

Work Rights

Not specified

Tailored Resume

Cover Letter