Research Associate- MCG- 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 https://(Use the "Apply for this Job" box below). 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:// 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://.

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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 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 and population health, social, behavioral, and educational research. Community education, well-defined research initiation process, ongoing and continued support for conduct of research, and integrated and technology advanced IT systems to support efficient research processes.

Job Summary

The Research Associate in this position will provide assistance to the overall functioning activities of the Clinical Trials Office (CTO). The CTO is an interdisciplinary research unit that provides support for physician-initiated, grant-funded, and industry sponsored clinical trials.

Responsibilities

Responsibilities to include, but are not limited to:

Recruitment of new study participants to include screening/randomization; management of study documents, regulatory, data entry and as requested assist with unfunded and/or investigator- initiated studies.

Review studies to develop strategies for enrollment. Schedule pre-site visits, site initiation visits, study start up visits and monitoring visits.

Ability to work as a team player to include responding to all correspondence in a timely manner and adjusting daily schedules to accommodate both the patient and investigator.

Keep investigator informed of patient conditions, provide assistance to investigators in the management of adverse events to include changing the workflow to accommodate study amendments and principal investigator directions.

Serve as patient advocates, scheduling follow-up appointments, coordinate care with other departments, perform all laboratory and other tests as required by the protocol. Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies.

Maintain all FDA, sponsor, and institutional review board documentation. Obtain and maintain complete source documentation. Accurate and timely completion of all case report forms and other data entry as required by the sponsor and local institutional data management programs.

As requested assist with audit preparation as well as respond to internal…