Regulatory Compliance Specialist - Clinical Trials Office

Regulatory Compliance Specialist - Clinical Trials Office

Job : 291193 Location: Augusta University Full/Part Time: Full Time

About Us

Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 12,000 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences.

Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values are reflected in our operations and expectations for the Augusta University community.

Location

Augusta University – Health Sciences Campus: 1120 15th Street, Augusta, GA 30912
Summerville Campus: 2500 Walton Way, Augusta, GA 30904

College/Department Information

Augusta University conducts research, including extensive clinical trials in humans (human subject research). There are federal requirements that must be met to conduct human subject research. Our group includes researchers, administrators, and office staff who support this work, with strengths in conventional clinical trials, community and population health research, ongoing research support, and integrated IT systems to support efficient processes.

Job Summary

The incumbent will work closely with the Clinical Research Team to support and advance clinical trials operations. Responsibilities include preparing and submitting Institutional Review Board (IRB) applications, regulatory submissions, and related documentation to ensure full compliance with human subject research regulations. This role will also focus on streamlining processes to improve efficiency, maintaining regulatory integrity, and supporting the growth of the Clinical Trials Office (CTO) clinical research program.

Responsibilities

• Obtaining required research education certificates and documentation from clinical staff and principal investigators to ensure IRB protocol submission is submitted in accordance with all federal rules and regulations.
• Work to complete IRB protocol submissions for all new studies, active study amendments and study continuations/renewals from study startup to closeout.
• As needed, register, and update the Oncore task list.
• Assist with review/audit clinical research protocols for compliance with the terms and conditions of the IRB approval and IRB approved sponsor protocol at the time of participant enrollment, sponsor, or grant agreement, governing laws and regulations, Good Clinical Practice (GCP), and AU policies/procedures.
• Assist and collaborate with internal/external customers during regulatory compliance audits to include responding to management inquiries.
• Actively participate in research regulatory meetings and provide suggestions for appropriate solutions.
• Attend all study startup, PSIV and SIV meetings as requested.
• As requested, assist with the completion of all startup activities and during regulatory and compliance audits as needed (e.g., gathering documentation, responding to inquiries).
• Assist in training staff related to IRB protocol submission and required documentation.
• Participate in regulatory meetings related to all funded studies. Back up for study startup activities and back up monitor security requests.

Required Qualifications

• High School Diploma or GED and 5 years of related experience OR Associate degree and 3 years of related experience.

Knowledge, Skills, & Abilities

• KNOWLEDGE
  • Proficient in Microsoft Office and other computer software/databases.
  • Knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trials research.
  • Research study regulatory processes for human subject research.
  • Experience in Electronic Medical Records and Electronic Clinical Research Monitoring Systems (OnCore).
• SKILLS
  • Excellent interpersonal, written, and verbal communication skills.
  • Detail-oriented with strong…