Augusta University
Regulatory Compliance Specialist - Clinical Trials Office
Augusta University, Augusta, Georgia, United States, 30910
Regulatory Compliance Specialist - Clinical Trials Office
Job ID:
291193
Location:
Augusta University
Full/Part Time:
Full Time
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 are reflected in our operations and expectations for the Augusta University community.
Location
Augusta University – Health Sciences Campus: 1120 15th Street, Augusta, GA 30912
Summerville Campus: 2500 Walton Way, Augusta, GA 30904
College/Department Information
Augusta University conducts research, including extensive clinical trials in humans (human subject research). There are federal requirements that must be met to conduct human subject research. Our group includes researchers, administrators, and office staff who support this work, with strengths in conventional clinical trials, community and population health research, ongoing research support, and integrated IT systems to support efficient processes.
Job Summary
The incumbent will work closely with the Clinical Research Team to support and advance clinical trials operations. Responsibilities include preparing and submitting Institutional Review Board (IRB) applications, regulatory submissions, and related documentation to ensure full compliance with human subject research regulations. This role will also focus on streamlining processes to improve efficiency, maintaining regulatory integrity, and supporting the growth of the Clinical Trials Office (CTO) clinical research program.
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.
As requested, assist with the completion of all startup activities and during regulatory and compliance audits as needed (e.g., gathering documentation, responding to inquiries).
Assist in training staff related to IRB protocol submission and required documentation.
Participate in regulatory meetings related to all funded studies. Back up for study startup activities and back up monitor security requests.
Required Qualifications
High School Diploma or GED and 5 years of related experience OR Associate degree and 3 years of related experience.
Knowledge, Skills, & Abilities
KNOWLEDGE
Proficient in Microsoft Office and other computer software/databases.
Knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trials research.
Research study regulatory processes for human subject research.
Experience in Electronic Medical Records and Electronic Clinical Research Monitoring Systems (OnCore).
SKILLS
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong prioritization, organizational, typing and multi-tasking skills.
ABILITIES
Ability to maintain confidentiality and make responsible decisions.
Demonstrated flexibility regarding job duties/assignments.
Must possess a high degree of urgency, self-motivation, integrity, and a strong work ethic.
Ability to manage and respond to a variety of situations in a professional and courteous manner.
Study regulatory material management and processes for meeting coordination and task management.
Shift/Salary/Benefits
Shift: Days; Monday - Friday (Work outside of normal business hours may be required).
Salary: $20.29-$25.34/hourly.
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 information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond.
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. Applications and Job ID 291193 can be found by visiting the Augusta University jobs page or the USG careers portal. If you need further assistance, please contact us at 706-721-9365.
To apply, visit the careers portal and search for Job ID 291193. Select University Faculty & Staff > External Applicants if you are a candidate from outside the university, or External Applicants as applicable if you are a current university employee.
All rights reserved.
#J-18808-Ljbffr
291193
Location:
Augusta University
Full/Part Time:
Full Time
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 are reflected in our operations and expectations for the Augusta University community.
Location
Augusta University – Health Sciences Campus: 1120 15th Street, Augusta, GA 30912
Summerville Campus: 2500 Walton Way, Augusta, GA 30904
College/Department Information
Augusta University conducts research, including extensive clinical trials in humans (human subject research). There are federal requirements that must be met to conduct human subject research. Our group includes researchers, administrators, and office staff who support this work, with strengths in conventional clinical trials, community and population health research, ongoing research support, and integrated IT systems to support efficient processes.
Job Summary
The incumbent will work closely with the Clinical Research Team to support and advance clinical trials operations. Responsibilities include preparing and submitting Institutional Review Board (IRB) applications, regulatory submissions, and related documentation to ensure full compliance with human subject research regulations. This role will also focus on streamlining processes to improve efficiency, maintaining regulatory integrity, and supporting the growth of the Clinical Trials Office (CTO) clinical research program.
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.
As requested, assist with the completion of all startup activities and during regulatory and compliance audits as needed (e.g., gathering documentation, responding to inquiries).
Assist in training staff related to IRB protocol submission and required documentation.
Participate in regulatory meetings related to all funded studies. Back up for study startup activities and back up monitor security requests.
Required Qualifications
High School Diploma or GED and 5 years of related experience OR Associate degree and 3 years of related experience.
Knowledge, Skills, & Abilities
KNOWLEDGE
Proficient in Microsoft Office and other computer software/databases.
Knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trials research.
Research study regulatory processes for human subject research.
Experience in Electronic Medical Records and Electronic Clinical Research Monitoring Systems (OnCore).
SKILLS
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong prioritization, organizational, typing and multi-tasking skills.
ABILITIES
Ability to maintain confidentiality and make responsible decisions.
Demonstrated flexibility regarding job duties/assignments.
Must possess a high degree of urgency, self-motivation, integrity, and a strong work ethic.
Ability to manage and respond to a variety of situations in a professional and courteous manner.
Study regulatory material management and processes for meeting coordination and task management.
Shift/Salary/Benefits
Shift: Days; Monday - Friday (Work outside of normal business hours may be required).
Salary: $20.29-$25.34/hourly.
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 information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond.
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. Applications and Job ID 291193 can be found by visiting the Augusta University jobs page or the USG careers portal. If you need further assistance, please contact us at 706-721-9365.
To apply, visit the careers portal and search for Job ID 291193. Select University Faculty & Staff > External Applicants if you are a candidate from outside the university, or External Applicants as applicable if you are a current university employee.
All rights reserved.
#J-18808-Ljbffr