The University of Arkansas for Medical Sciences (UAMS) is
seeking an experienced and innovative leader for the position of
Director of Research Regulatory Affairs. The Director of Research
Regulatory Affairs will oversee three sub-departments (Regulatory
Unit, Monitoring Unit and Quality Assurance), along with the
business administration of ORRA. The Director also guides strategic
planning and development of organizational goals and objectives and
ensures those goals are accomplished. The Director shall report to
the Vice Chancellor of Research & Innovation.
About Research and Innovation and the Office of Research
The Division of Research and Innovation (R&I) provides
leadership in formulating and enacting strategies to expand
system-wide research activities. As Arkansas’s only academic health
center, No. 1 public biomedical research institution, and “Best
Hospital,” UAMS enjoyed another year of double-digit growth (~14%)
in competitive research awards in FY2021. Our faculty won 326
grants and contracts, totaling $143 million from extramural
sponsors in FY2021.
The UAMS ORRA provides assistance to Investigators who conduct
clinical and translational research for Investigator-Initiated
studies that require an IND or IDE. ORRA is a diverse team of
experienced professionals tasked with helping Investigators
navigate the complicated and changing federal, state and
ORRA Director Roles and Responsibilities:
- Supervise regulatory activities for investigator-initiated IND,
IDE and expanded access studies in which ORRA acts as Sponsor on
behalf of UAMS. Assure that appropriate regulatory, QA (Quality
Assurance) and monitoring activities and personnel are available
for investigator-initiated clinical research.
- Supervise review of protocols for feasibility and ability to
accomplish research objectives.
- Develop and implement a risk-based assessment for clinical
research projects conducted at the UAMS campus including assessment
of regulatory risk.
- Assure that trained personnel are available to monitor
compliance with GMP (Good Manufacturing Practices) of novel
products. Assure trained personnel are available to inspect
facilities requiring GTP (Good Tissue Practice) certification.
- Ensure accuracy of regulatory filings and campus-wide
compliance of clinicaltrials.gov registration and maintenance.
Communicates with ORRA team members, the VCRI and the campus
research community regarding project status and issues.
- Create a service-oriented approach to assist investigators and
other research staff with tasks assigned to the ORRA by VCRI.
- Develop and implement appropriate policies and SOPs to support
the mission of ORRA. Ensure staff are trained on and comply with
- Develop and oversee preparation of ORRA’s annual budget.
Supervise dispensation of office funds and preparation of periodic
- Supervise preparation of annual reports, and other department
reports as requested by campus leadership.
The ideal candidate will have the following professional
qualifications and personal characteristics:
- Master’s degree or equivalent education in Scientific or Health
Related field plus 6 years of experience in research with an
emphasis on regulatory affairs, including 1 to 3 years management
experience and 5 years regulatory experience related to assessing
need for IND/IDE and FDA submission requirements
- Relevant certification as a Certified Clinical Research
Professionals (CCRP), Certified Clinical Research Associate (CCRA),
Certified Clinical Research Coordinator (CCRC), or Certified IRB
- Knowledge of clinical trials principles, methodology,
guidelines and reporting procedures and standards
- MD/DO, RN, or Ph.D. is preferred
- Advanced ability to coordinate multiple projects and
flexibility in adjusting daily workload priorities.
- Ability to communicate effectively, orally and in writing, with
employees and all other internal and external contacts.
- Critically review clinical research protocols.
- High emotional intelligence, organizational, leadership,
reasoning, and interpersonal skills.
- Ability to lead and motivate others; ability to meet deadlines,
take initiative and make decisions within internal/external
- Extensive knowledge of ICH GCP guidelines, FDA Regulations 312,
812, 1271 and IRB policies and procedures.
- Computer-literacy in Microsoft Outlook, Word, Excel, Access and
For full consideration, applications should be received by July
15, 2022, and include the following documents:
- A resume or curriculum vitae
- A letter of interest providing a concise summary of
qualifications for this leadership position.
Applications and nominations should be submitted to email@example.com, Duchess
Johnson, Senior Manager-UAMS Executive Search Group.
UAMS is an inclusive Affirmative Action and Equal
Opportunity Employer of individuals with disabilities and protected
veterans and is committed to excellence.
The safety of our team members at the University of Arkansas
for Medical Sciences is our top priority. For this reason,
successful applicants for this position must be fully vaccinated
against Covid-19 or have filed a request for medical or religious
exemption as a condition of employment. UAMS will adhere to
all federal, state and local regulations and will obtain necessary
proof of vaccination prior to employment to ensure