Data Coordinator 2 - Oncology Clinical Trials
Job ID: 282431
Location: Augusta University
Full/Part Time: Full Time
Regular/Temporary:
*

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 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.
The University System of Georgia https://www.usg.edu/hr/orientation/welcome_to_the_board_of_regents_university_system_office 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/#p8.2.18_personnel_conduct.
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.
Location
Augusta University - Health Sciences Campus: 1120 15th Street, Augusta, GA 30912
College/Department Information
The Georgia Cancer Center is on a mission for providing industry-leading cancer research and care that benefits patients locally and globally. Our ultimate goal is to eradicate cancer and we are proudly making progress every day. When we say patient care is a priority, we mean it. We assemble custom teams of field experts to address each individual's unique needs.
The research and innovations developed at the Georgia Cancer Center ultimately influence the global network of cancer care. Our team fights for far more than just Georgians. The learnings achieved through the care of local patients has wide-reaching implications for creating tomorrow's standard of cancer care. Through facilitating first-in-the-nation trials and growing a depth of understanding only available through a multidisciplinary approach, the Georgia Cancer Center team is equipped to deliver treatment advancements that will be applied in facilities across the world. The team offers a proving ground that paves the way for patients in other areas to have access to new options.
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 duties 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 access to various portals, including any new portals the study team may be required to access.
Perform all other job-related duties as assigned.
Required Qualifications
Associate's degree from an accredited college or university.
OR
Completion of two years of college level coursework and two years of related work experience.
Preferred Qualifications
Bachelor's degree from an accredited college or university. Experience related to clinical setting or research setting.
Knowledge, Skills, & Abilities
Proficient in Microsoft Office and other computer software/databases as well as the ability to learn how to navigate online tools like IRB.net and OnCore..
SKILLS
Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong prioritization and organizational skills.
ABILITIES
Ability to maintain confidentiality.
Shift/Salary/Benefits
Shift: Days; Monday - Friday.
Pay Band: B6
Salary Minimum: $18.85 - Midpoint: $23.56
Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position
Recruitment Period: 3/7/25 - 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.
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.
Equal Employment Opportunity
Augusta University is proud to be an equal opportunity employer welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.
How To Apply
Consider applying with us today!
Search for Job ID: 282431
https://www.augusta.edu/hr/jobs/
Select University Faculty & Staff > External Applicants if you are a candidate from outside the university
Select University Faculty & Staff > Internal Applicants if you are a current university employee
If you need further assistance, please contact us at 706-721-9365
To apply, visit https://careers.hprod.onehcm.usg.edu/psp/careers/CAREERS/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=12000&JobOpeningId=282431&PostingSeq=1
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