Research Associate

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 make Augusta University an institution like no other.
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 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

Performs advanced administrative and technical work in support of clinical research trials. Manages several large, multi-center, investigator-initiated, federal, and industry sponsored clinical trials.

REQUIRED QUALIFICATIONS

Master’s degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and experience in research, basic science or clinical laboratory particularly clinical trial research.
OR
Bachelor’s degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and a minimum of three years’ research and/or clinical experience; previous supervisory experience.

PREFERRED QUALIFICATIONS

Clinical Research Professional/Associate/etc. certificates.

KNOWLEDGE, SKILLS, & ABILITIES

Must have knowledge of FDA/GCP regulations and adequate computer skills (Word, Excel, Adobe Acrobat) as well as the ability to learn (if needed) how to navigate online tools like IRB.net and OnCore.
Ability to maintain confidentiality.
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong prioritization and organizational skills.
Proficient in Microsoft Office and other computer software/databases.

Responsibilities include, but are not limited to:

• Prepares new clinical trial research protocols for IRB submission, in compliance with all applicable regulations and policies of FDA, DHHS, ICH, state of Georgia, AU, and AUMC. Coordinates activities with respective campus departments to ensure successful study execution.
• Performs regulatory activities associated with the ongoing management of current clinical research protocols, including, but not limited to, protocol amendments, financial disclosure, protocol deviations, protocol departures, adverse events.
• Responsible for uploading regulatory documents into OnCore and IRBNet. Provides regulatory support to cancer center clinical investigators and clinical staff. Acts as a liaison between clinical trial sponsors (or contract research organizations), clinical investigators, and the IRB, and coordinates efforts towards the startup and ongoing conduction of a clinical trial until close out of study.
• Creates and maintains training schedule for Cancer Center research faculty and staff related to research compliance best practices. Assists with finding and distributing continuing education requirement opportunities. Performs quality control regulatory inspections of cancer center clinical trials to ensure regulatory compliance.
• Perform all other job-related duties as assigned.