Inside Higher Ed
Regulatory Compliance Specialist - Clinical Trials Office
Inside Higher Ed, Augusta, Georgia, United States, 30910
Regulatory Compliance Specialist - Clinical Trials Office
Join to apply for the
Regulatory Compliance Specialist - Clinical Trials Office
role at
Inside Higher Ed
5 days ago Be among the first 25 applicants
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 (https://www.augusta.edu/about/mission.php) make Augusta University an institution like no other.
Job ID:
291193
Location:
Augusta University
Full/Part Time:
Full Time
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
Obtain required research education certificates and documentation from clinical staff and principal investigators to ensure IRB protocol submission complies with all federal rules and regulations.
Complete IRB protocol submissions for all new studies, active study amendments, and study continuations/renewals from study startup to closeout.
Register and update the Oncore task list as needed.
Assist with review and audit of clinical research protocols for compliance with the terms and conditions of IRB approval and sponsor protocol at participant enrollment, sponsor, or grant agreement, governing laws and regulations, Good Clinical Practice (GCP), and AU policies/procedures.
Assist and collaborate with internal and external customers during regulatory compliance audits, including 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.
Assist with the completion of all startup activities and with regulatory and compliance audits as needed, gathering documentation and responding to management inquiries.
Assist in training staff on IRB protocol submission and required documentation.
Participate in regulatory meetings related to all funded studies. Backup study startup activities and 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; knowledge of research study regulatory processes for human subject research; experience with 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; 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). Recruitment Period: Until Filled. Benefits include health, dental, and life insurance; payroll deductions for retirement plans; earned vacation time, sick leave, and 13 paid holidays; tuition assistance program for employees eligible after 6 months of employment.
Conditions of Employment All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University. Depending on duties, a credit check may be required for Positions of Trust or approved departmental Purchase Card usage. Motor vehicle reports are required for positions that require driving an Augusta University vehicle. Faculty hires must provide proof of completed academic degree(s) and post‑secondary coursework on original transcripts; foreign‑trained candidates must provide an educational/credential evaluation.
All employees are responsible for ensuring confidentiality, availability, and integrity of sensitive information in accordance with cybersecurity and privacy policies.
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! Visit
https://www.augusta.edu/hr/jobs/
search for Job ID: 291193.
#J-18808-Ljbffr
Regulatory Compliance Specialist - Clinical Trials Office
role at
Inside Higher Ed
5 days ago Be among the first 25 applicants
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 (https://www.augusta.edu/about/mission.php) make Augusta University an institution like no other.
Job ID:
291193
Location:
Augusta University
Full/Part Time:
Full Time
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
Obtain required research education certificates and documentation from clinical staff and principal investigators to ensure IRB protocol submission complies with all federal rules and regulations.
Complete IRB protocol submissions for all new studies, active study amendments, and study continuations/renewals from study startup to closeout.
Register and update the Oncore task list as needed.
Assist with review and audit of clinical research protocols for compliance with the terms and conditions of IRB approval and sponsor protocol at participant enrollment, sponsor, or grant agreement, governing laws and regulations, Good Clinical Practice (GCP), and AU policies/procedures.
Assist and collaborate with internal and external customers during regulatory compliance audits, including 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.
Assist with the completion of all startup activities and with regulatory and compliance audits as needed, gathering documentation and responding to management inquiries.
Assist in training staff on IRB protocol submission and required documentation.
Participate in regulatory meetings related to all funded studies. Backup study startup activities and 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; knowledge of research study regulatory processes for human subject research; experience with 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; 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). Recruitment Period: Until Filled. Benefits include health, dental, and life insurance; payroll deductions for retirement plans; earned vacation time, sick leave, and 13 paid holidays; tuition assistance program for employees eligible after 6 months of employment.
Conditions of Employment All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University. Depending on duties, a credit check may be required for Positions of Trust or approved departmental Purchase Card usage. Motor vehicle reports are required for positions that require driving an Augusta University vehicle. Faculty hires must provide proof of completed academic degree(s) and post‑secondary coursework on original transcripts; foreign‑trained candidates must provide an educational/credential evaluation.
All employees are responsible for ensuring confidentiality, availability, and integrity of sensitive information in accordance with cybersecurity and privacy policies.
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! Visit
https://www.augusta.edu/hr/jobs/
search for Job ID: 291193.
#J-18808-Ljbffr