Regulatory Compliance Specialist - Clinical & Translational Science

at  Augusta University

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 10,500 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 https://www.augusta.edu/about/mission.php 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 https://www.usg.edu/hr/orientation/welcometotheboardofregentsuniversitysystemoffice 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 https://www.usg.edu/policymanual/section8/C224/#p8.2.18personnelconduct.
Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at https://www.usg.edu/policymanual/section6/C2653.

JOB SUMMARY

This incumbent will work with the research team on IRB regulatory submissions to ensure compliance with human subject research, improve efficiency, fiscal soundness and to grow CTO clinical research.

REQUIRED QUALIFICATIONS

Associate’s degree from an accredited college or university with three years’ related experience.
OR
High School Diploma, GED, or equivalent from a recognized State or Federal accrediting organization with five years’ related experience.

KNOWLEDGE

Proficient in Microsoft Office and other computer software/databases. Knowledge of Electronic Medical Records and Electronic Clinical Research Monitoring Systems (OnCore). Knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trials; research study regulatory material management; and processes for meeting coordination and task management.

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 assignments. Must possess a high degree of urgency, self-motivation, integrity, and have a strong work ethic. Ability to manage and respond to a variety of situations in a professional and courteous manner.

REGULATORY 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.