Data Coordinator 2- GCC Oncology Trials

Job Summary

This position performs a variety of complex duties involved providing regulatory support for the regulatory coordinators within the CTO. Duties include, but are not limited to: provide regulatory support as lead regulatory coordinator for studies, assist with sponsored and investigator-initiated trial IRB submissions including initial submissions, amendments, continuation and annual reports (completion of study documents, IRB forms, etc., as needed for each submission), IND safety reports, ensuring the submissions are in compliance within federal, state and local regulations; assist with obtaining local approvals (biosafety, radiation safety, IT requests, etc.); obtaining electronic and ink signatures, assist with submissions to the FDA for the investigator-initiated studies (initial IND requests, amendments and annual reports, submitting hard copies of each submission to the FDA) and completion of FDA forms; procurement of medical/lab supplies and creation of lab kits for investigator-initiated studies; assist in ensuring lab kits and other study materials are obtained for sponsored studies; assist in the creation of forms including source documents, case report forms and manuals (operations, CRF and lab manuals) and standard operating procedures (SOPs).

Responsibilities

The responsibilities to include, but are not limited to:

• Responsible for onboarding new employees and investigators who wish to conduct clinical trials at the Georgia Cancer Center, including ensuring appropriate documentation is gathered, training is done, and access to the appropriate portals is granted.
• Responsible for adding new personnel onto each study they will serve as site staff on. This includes submitting to the AU IRB, routing training, and getting the appropriate documentation signed before site staff participates in a study.
• Responsible for updating personnel responsibilities on a study, removing personnel who have left the institution, and granting accesses to various portals, including any new portals the study team may be required to access
• Other 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; Certification from the Association of Clinical Research Professionals as a Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA).

Knowledge, Skills, & Abilities

Proficient in Microsoft Office and other computer software/databases.

SKILLS

High attention to detail and change management.

Excellent interpersonal, written, and verbal communication skills.

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

ABILITIES

Ability to maintain confidentiality.

Shift/Salary/Benefits

Shift: Days/M-F

Pay Band: B6

Salary Range: $18.85-$23.56 per hour.

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

This position is (fully/partially) funded through external sources. Continued employment is contingent upon the availability of these funds.

Recruitment Period: 4/20/26 - 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. Consider applying with us today!

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.