Regulatory Compliance Specialist - Clinical Investigative Services

Job ID: 276234
Location: Augusta University
Full/Part Time: Full Time
Regular/Temporary:

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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 make Augusta University an institution like no other.

The University System of Georgia 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-

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

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

College/Department Information

At Augusta University, research takes prominence by taking place everywhere and among everyone: in wet labs and archives, with senior investigators and sophomore classes, in our health care facilities and our community. Research aims to advance knowledge that addresses the cultural, economic, health and societal needs of the communities we serve through research, scholarship, and creativity.

Job Summary

This incumbent will work with the research team on IRB regulatory submissions to ensure compliance with human subject research, improve efficiency, fiscal soundness and to grow CTO clinical research.

Responsibilities

The duties include, but are not limited to:

Regulatory Responsibilities: Obtaining required research education certificates and documentation from clinical staff and principal investigators to ensure IRB protocol submission is submitted in accordance with all federal rules and regulations. Work to complete IRB protocol submissions for all new studies, active study amendments and study continuations/renewals from study startup to closeout as needed, register, and update the Oncore task list. Assist with review/audit clinical research protocols for compliance with the terms and conditions of the IRB approval and IRB approved sponsor protocol at the time of participant enrollment, sponsor, or grant agreement, governing laws and regulations, Good Clinical Practice (GCP), and AU policies/procedures. Assist and collaborate with internal/external customers during regulatory compliance audits to include responding to management inquiries. Actively participate in research regulatory meetings and provide suggestions for appropriate solutions. Attend all study startup, PSIV and SIV meetings as requested.

Study Startup Activities: As requested, assist with the completion of all startup activities. As requested, assist during regulatory and compliance audits as needed (Le, gathering documentation as requested, responding to management inquires). Assist in training of staff as related to IRB protocol submission and required documentation Participate in regulatory meetings as related to all funded studies.

Other Duties: Back up for study startup activities. Back up monitor security requests. Perform other related duties as assigned.

Required Qualifications

High School Diploma, GED, or equivalent from a recognized State or Federal accrediting organization and five years of related experience.

OR

Associate's degree from an accredited college or university and three years related experience.

Preferred Qualifications

Preferred Educational Qualifications
Registered Nurse; Certified Research Coordinator (CCRC); or Certified Clinical Research Professional

Preferred Experience
Expertise in human subject protection, regulatory functions and clinical trial data management systems.

Knowledge, Skills, & Abilities

ABILITIES
Ability to maintain confidentiality.

KNOWLEDGE
FDA regulations and GCP/ICH guidelines regarding clinical trials.
Research study regulatory processes for human subject research.

SKILLS
Well-developed interpersonal skills.
Exceptional organizational skills with attention to detail.
Excellent verbal and written communication skills.

Shift/Salary/Benefits

Shift: Days; Monday - Friday (Work outside of normal business hours may be required).

Pay Band: B7

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

Recruitment Period: 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!

https://www.augusta.edu/hr/jobs/ Search for Job ID: 276234.

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=276234&PostingSeq=1

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