Data Coordinator 2

University System of Georgia

Georgia

On-site

USD 39,000 - 42,000

Full time

4 days ago
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Job summary

Augusta University in Augusta, GA, is seeking a regulatory support professional for investigator-initiated trials within the GCC CTO. The role assists with IRB submissions, FDA reporting, and SIV preparation, ensuring compliance with federal, state, and local regulations.

Candidates will coordinate IRB forms, provide meeting facilitation support, manage OnCore access, and perform additional duties to support study teams in a fast-paced research environment.

Qualifications

  • Associate's degree in a related field.
  • Two years of college + two years related work experience.

Responsibilities

  • IRB submission support for local IRB and regulatory forms.
  • SIV meeting facilitation and FDA annual report support.
  • Provide access and data coordination in OnCore for study teams.
  • Perform additional duties as assigned.

Skills

Confidentiality
Attention to detail
Communication skills
Microsoft Office
Time management

Education

Associate's degree in a related field
Two years of college + two years related work experience

Tools

OnCore

Job description

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://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.

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

College/Department Information

The Medical College of Georgia (MCG) is one of the nation's largest medical schools by class size, with 304 students per class. The MCG educational experience is anchored by the main campus in Augusta, with regional clinical campuses for third- and fourth-year students across the state, and two four-year campuses located in Athens (in partnership with the University of Georgia) and in Savannah (in partnership with Georgia Southern University). MCG's expanding partnerships with physicians and hospitals across Georgia currently provide more than 350 sites where students can experience the full spectrum of medicine, from complex care hospitals to small-town solo practices. MCG and its teaching hospitals also provide postgraduate education to approximately 575 residents and fellows in 50 different Accreditation Council for Graduate Medical Education-approved programs. Our researchers and clinicians focus on what most impacts the health of Georgia's and America's children and adults, including cardiovascular biology and disease, cancer, neurosciences and behavioral sciences, public and preventive health, regenerative and reparative medicine, personalized medicine and genomics. Our physician faculty also share their expertise with physicians and patients at about 100 clinics and hospitals statewide.

Job Summary

This position performs a variety of complex duties involved in providing regulatory support for the investigator-initiated trials program in the GCC CTO. Duties include but are not limited to: assist with investigator-initiated IRB submissions including personnel amendments, continuation reports and annual reports (completion of IRB forms and other regulatory forms as needed for each submission), ensuring the submissions are in compliance within federal, stage, and local regulations; assist with submissions to the FDA (annual reports) and completion of FDA forms. Additionally, this position will assist in the preparation of the SIV.

Responsibilities

The duties include, but are not limited to:

  • IRB submission support includes the local IRB; completion of all IRB and submission forms, obtaining signatures, completion of training, delegation of duties logs, and all forms pertinent to each submission, etc.
  • Meeting Facilitator support includes assisting in the preparation and facilitation of SIV meetings.
  • FDA submissions support includes assisting in the submission of annual reports to the FDA including completion of FDA forms.
  • Software access & data coordination Provide access for study team members in OnCore; track and update study status, task lists.
  • Perform all other additional duties as assigned.
Required Qualifications

Associate's degree from an accredited college or university in a related field.

OR

Completion of two years of college level coursework and two years of related work experience.

Preferred Qualifications

Oncology research specific knowledge and experience preferred. Familiarity with medical terminology. Experience in database management software preferably OnCore.

Knowledge, Skills, & Abilities

Ability to maintain confidentiality

High attention to detail and change management

Excellent interpersonal, written and verbal communication skills

Proficient in Microsoft Office and other computer software/databases

Detail-oriented with strong prioritization, multi-tasking, organizational, problem-solving and time-management skills

Shift/Salary/Benefits

Shift: Days/M-F

Pay Band: B6

Salary Minimum: $18.85/hourly

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

Recruitment Period: 10/5/26 - 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.

Conditions of Employment

All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University.

If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and or approved departmental Purchase Card usage.

Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle.

For Faculty Hires: Final candidates will be required to provide proof of completed academic degree(s) as well as post-secondary coursework in the form of original transcript(s). Those candidates trained by a foreign institution will also be required to provide an educational/credential evaluation.

All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond.

Other Information

This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success."

Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited.

Augusta University is proud to be an equal opportunity employer welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.

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