Regulatory Compliance Coordinator

  • Augusta University
  • Augusta, GA, USA
  • Dec 03, 2022
Full time Other Administrative Positions

Job Description

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Regulatory Compliance Coordinator

Augusta University



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 9,000 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.

Location

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

College/Department Information

The Clinical Trials Office (CTO) serves as the initial point of contact and centralized coordinating office for all clinical research conducted within the Augusta University Health System. Our mission is to facilitate clinical research by providing quality services, solutions, innovative leadership, the promotion of collaboration, and continuous quality improvement. Our operation is based upon a comprehensive "One Stop Shop" concept for investigators and sponsors. The Clinical Trials Office provides oversight and management of clinical studies.

Job Summary

This incumbent will work with research leadership and administrators to implement regulatory processes for human subject research that improve efficiency, fiscal soundness and to grow CTO clinical research. As a key member of the CTO leadership team, this individual will supervise regulatory operations to include monitoring workloads and development of regulatory training/mentoring programs. This position will supervise the Regulatory Compliance Coordinator I and II positions.

Responsibilities

Duties include, but are not limited to:

Regulatory Responsibilities
Liaison between AU and External sponsors for IRB regulatory submissions; Meet with Faculty and Staff to discuss issues and propose solutions for IRB regulatory submissions; Work collaboratively with the Director and Managers to assess study feasibility prior to study startup; Analyze information, situations, policies & procedures to assess and define problems, identify relevant issues, concerns, and implications, formulate alternatives for resolutions as well as other federal regulations; 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; 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; Supervise staff and work to complete IRB protocol submissions for all new studies, active study amendments and study continuations/renewals from study startup to closeout; Lead and collaborate with internal/external customers during regulatory compliance audits to include responding to management inquires; Participate in research regulatory meetings and provide suggestions for appropriate solutions; Attend all study startup, PSIV and SIV meetings; Develop, update and revise/maintain department standards and policies related to regulatory.

Study Startup Activities
Oversee and troubleshoot startup activity issues with both internal and external customers.

Other Duties
Perform other related duties as assigned.

Required Qualifications

Bachelor's degree in related field with a minimum of four years of experience or Master's degree in related field with a minimum of one year of experience.

Preferred Qualifications

Certified Research Coordinator (CCRC) or Certified Clinical Research Professional
Registered Nurse; Certified Clinical Research Coordinator (CCRC); Expertise in human subject protection, regulatory functions and clinical trial data management systems.

Knowledge, Skills, & Abilities

Excellent interpersonal, written and verbal communication skills
Proficient in Microsoft Office and other computer software/databases
Ability to maintain confidentiality, make sound financial and personnel decisions
Detail-oriented and self-motivated with strong organizational, prioritization and multi-tasking skills
FDA regulations and GCP/ICH guidelines regarding clinical trials.
Research study regulatory processes for human subject research.
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 Grade: 16

Salary: $41,846/annually - $47,950.76/annually

Salary to be commensurate with qualifications of 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 candidates are required to successfully pass a Background Check review prior to starting with Augusta University.
The primary work location for this position is within the Augusta University Medical Center or other Augusta University Health System Clinic Space and is subject to the Centers for Medicare & Medicaid Services guidelines. The selected candidate will be required to provide proof of COVID vaccination or an approved exemption. Your application to this position confirms you are aware of this requirement and agree to provide proof of either COVID vaccination or our organization's approval of a medical or religious exemption.
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 the course of 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 everyday 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/
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, please 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=250917&PostingSeq=1






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