Research Associate- Clinical Trials Office

Overview

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

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

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

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. We conduct research, much of which is done through human subject research. There are federal requirements that all research institutions must meet to conduct human subject research. We have an outstanding, dynamic, and growing group of researchers, administrators, and office staff ready to assist.

Our strengths include:

• 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

The Research Associate provides assistance to the Clinical Trials Office (CTO), an interdisciplinary unit that supports physician-initiated, grant-funded, and industry-sponsored clinical trials.

• Coordinate clinical research trials: meet with drug company representatives, screen, recruit and consent patients, schedule follow-up appointments, coordinate care with other departments, and perform required laboratory and other tests per protocol.
• Receive and respond to correspondence in a timely manner.
• Keep investigators informed of patients’ conditions and assist with adverse event management.
• Attend meetings, computer trainings, and workshops as requested.
• Complete all reports in a timely manner, communicating necessary information to patients, families, investigators, sponsor, IRB, and institutional entities.
• Manage collection, processing, storage, and inventory of specimens; assess adverse events; maintain investigational devices; complete regulatory paperwork per FDA, sponsor, and institutional policies.
• Maintain all FDA, sponsor, and IRB documentation; obtain and maintain complete source documentation; complete case report forms and data entry as required.
• Enter data into OnCore (research data management system) and Greenphire patient debit system as directed by policy.
• Review study bills for accuracy and correct coding according to the billing grid.
• Adapt workflow to study amendments and PI directions.
• Perform other job-related duties as assigned.

• Master’s degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or related natural, life, health care, or materials science with experience in research, basic science, or clinical laboratory work, particularly clinical trial research.
• OR
• Bachelor’s degree from an accredited college or university in Chemistry, Biology, Biochemistry, Cell Biology or related field with a minimum of three years of research and/or clinical experience.

• Completion of Citi Program (Learner group 1 FDA regulated research).
• CCRC, CCRA, or CCRP certification is highly desirable.
• BLS certification is a plus.

• KNOWLEDGE: Proficient in Microsoft Office and other computer software/databases.
• Skills: Excellent interpersonal, written, and verbal communication skills; detail-oriented with strong organizational skills.
• Abilities: Ability to maintain…