"Regulatory Compliance Specialist - Clinical Trials Office"

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 make Augusta University an institution like no other.

Augusta University's distinct characteristics in education and research include real-world experiences and community engagement, as well as a culture of building community, corporate and government partnerships that address health, security, economic and societal concerns locally and across the state.

The University System of Georgia is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found online at USG Board Policy 8.2.18.1.2.

Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at Board Policy 6.5.

Location

Augusta University

Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912

Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904

College/Department Information

Augusta University is actively participating in ways to improve the health and lives of the people of our community, our state, and around the world. To do this, we conduct research, a great deal of which is done through clinical trials in humans (known as human subject research). There are many federal requirements that all research institutions must meet in order to conduct human subject research. We have an outstanding, dynamic, and growing group of researchers, administrators, and office staff ready to assist. Our defined strengths lie in the areas of: Conventional clinical trials; Community, population health, social, behavioral, and educational research; Community education; Well-defined research initiation process; Ongoing and continued support for conduct of research; Integrated and technology advanced IT systems to support efficient research 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. As requested, assist during regulatory and compliance audits as needed (i.e., gathering documentation as requested, responding to management inquiries). Assist in training of staff as related to IRB protocol submission and required documentation. Participate in regulatory meetings as related to all funded studies. Back up for study startup activities. 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 prioritization, organizational, typing and multi-tasking skills.

ABILITIES

Ability to maintain confidentiality and make responsible decisions.

Demonstrated flexibility regarding job duties/assignments.

Must possess a high degree of urgency, self-motivation, integrity, and a strong work ethic.

Ability to manage and respond to a variety of situations in a professional and courteous manner.

Study regulatory material management and processes for meeting coordination and task management.

Shift/Salary/Benefits

Shift: Days; Monday - Friday (Work outside of normal business hours may be required).

Salary: $20.29-$25.34/hourly.

Pay Band: B7

Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position.

Recruitment Period: Until Filled.

Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees.

Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays.

Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program. Consider applying with us today!