Clinical Research Regulatory Coordinator I

St. Jude Affiliate Clinic is seeking a full-time Clinical Research Regulatory Coordinator I to support their clinical research team!

Work Schedule: Monday-Friday 8:30am-5:00pm

The Clinical Research Regulatory Coordinator I act as an agent of the investigators and research team conducting sponsored and independent clinical trials.. The purpose of the Clinical Research Regulatory Coordinator I is to perform study specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations (FDA Regulations, Good Clinical Practice Guidelines and ICH Guidelines) institutional policies, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes under the direction of their leader.

Dedicated to excellence in all aspects of clinical research with a keen focus on ethics, safety, quality, compliance, and stewardship.

• Education: High School Diploma or GED, Degree in health sciences or business, required. 4 Year / Bachelors Degree  Degree in health sciences or business, preferred.
• Experience:  Clinical Research and/or medical experience preferred. Customer service experience in a medical office or hospital preferred. Associate's degree may substitute for 1 year of experience or Bachelor's degree may substitute for 2 years of experience; Master's degree may substitute for 3 years of experience, preferred.
  Licensure/Certification: Certification (ACRP/SOCRA/equivalent), preferred.
• Additional Skills (required): Intermediate to advanced computer skills. Ability to read, understand and implement institutional review board policies and procedures, Code of Federal Regulations, Good Clinical Practice Guidelines, ICH guidelines and standard operating procedures. Medical terminology. Requires sitting, standing, walking, bending, stooping, and stretching. Requires wrist/hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, calculator, and other office equipment. Lifting up to 30 pounds is required. Requires corrected near vision and clear speech sufficient to communicate with physicians and staff. Possibility of exposure to body fluids.

Job responsibilities include:

• Coordinate regulatory activities for multiple clinical research studies, ensuring compliance with applicable guidelines and requirements
• Perform study-specific regulatory and safety reporting processes 
• Manage and maintain study-related data, ensuring accuracy, completeness, and regulatory compliance.
• Oversee and update patient lists and study participation
• Collaborate with research team members to ensure timely submission of regulatory documents and safety reports.
• Support audit readiness by ensuring documentation is complete and compliant across all assigned studies.
• Follow study protocols and operational plans under the direction of leadership to ensure efficient study conduct.