The Opportunity

Exterior of UAMS Medical Center

UAMS Medical Center

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

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 Division of Research & Innovation is divided into research support specialties:

BioVentures

  • 37 invention disclosures (FY20)
  • 20 new patent applications, and 5 U.S. patents granted (FY20)

Institutional Animal Care & Use Committee

  • 220+ active protocols from ~100 principal investigators and 25 departments/divisions
  • IACUC reviews an average of 9 new protocols/month, over 100/year

Institutional Review Board

  • Reviewed a total of 363 new human subject research projects in FY20 (full board, expedited, and exempt statuses)
  • 1,318 human subject protocols were open during FY20.

Office of Research Regulatory Affairs

  • 30 Active IND/IDE studies
  • Additional 9 studies in process of FDA submission or study start-up

Office of Research & Sponsored Programs

  • Processed over 500 proposals, with 272 to NIH (FY2020)
    • Submitted proposals included requests for $519 million.

 Office of Sponsored Programs Administrative Network

OSPAN is a Research & Innovation PI support team. This group of 27 research administrators and scientific editors (including SciCom) provides support for grant submissions and award administration. OSPAN has five team leads (of three to seven members each) for all UAMS’ colleges/divisions.

About the Office of Research Regulatory Affairs (ORRA)

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 institutional regulations.

Services

  • Regulatory Review, Submission and Maintenance of Studies
  • Determines need for IND/IDE; Assists with Expanded Access and Orphan Drug Applications
  • Acts as Sponsor on behalf of UAMS under IND/IDE Regulations
  • Prepares Initial Submission, Amendments, Safety Reports, Annual Progress Reports (APR) and Final Reports
  • ClinicalTrials.Gov Registrations, Maintenance and Final Reporting for all UAMS clinical trials
  • Clinical Trial Monitoring to ensure Human Subject rights/well-being, Compliance with Protocol and all applicable Regulations, and Quality Data
  • Assists with Preparation of Essential Documents
  • Conducts SIV/IMV/COV, verifies Investigational Product Accountability, and assist with Audits
  • Quality Assurance and Good Manufacturing Practice
  • Develops SOPs, Processes Investigational Product controls, Monitors IP Manufactured at UAMS/ACRI and provides Design Control for Medical Device Research
  • Good Tissue Practice for Arkansas Lions Eye Bank and Assisted Reproductive Technology (ART)Establish SOPs, Manages AEs/Deviations/Product Recalls, Conducts Inspections/Audits

About the University of Arkansas for Medical Sciences

aerial view of UAMS campus

UAMS main campus in Little Rock

UAMS is the state’s only health sciences university, with colleges of Medicine, Nursing, Pharmacy, Health Professions and Public Health; a graduate school; a hospital; a main campus in Little Rock; a Northwest Arkansas regional campus in Fayetteville; a statewide network of regional campuses; and seven institutes: the Winthrop P. Rockefeller Cancer Institute, Jackson T. Stephens Spine & Neurosciences Institute, Harvey & Bernice Jones Eye Institute, Psychiatric Research Institute, Donald W. Reynolds Institute on Aging, Translational Research Institute and Institute for Digital Health & Innovation. UAMS includes UAMS Health, a statewide health system that encompasses all of UAMS’ clinical enterprise. UAMS is the only adult Level 1 trauma center in the state. U.S. News & World Report recognized UAMS Medical Center as a Best Hospital for 2021-22; ranked its ear, nose and throat program among the top 50 nationwide for the third year; and named five areas as high performing — colon cancer surgery, diabetes, hip replacement, knee replacement and stroke. Forbes magazine ranked UAMS as seventh in the nation on its Best Employers for Diversity list. UAMS also ranked in the top 30% nationwide on Forbes’ Best Employers for Women list and was the only Arkansas employer included. UAMS has 3,047 students, 873 medical residents and fellows, and six dental residents. It is the state’s largest public employer with more than 10,000 employees, including 1,200 physicians who provide care to patients at UAMS, its regional campuses, Arkansas Children’s, the VA Medical Center and Baptist Health.

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 policies.
  • Develop and oversee preparation of ORRA’s annual budget. Supervise dispensation of office funds and preparation of periodic budget reports.
  • Supervise preparation of annual reports, and other department reports as requested by campus leadership.

Candidate Qualifications

The ideal candidate will have the following professional qualifications and personal characteristics:

Required Qualifications

  • Master’s degree or equivalent education in Scientific or Health Related field plus six years of experience in research with an emphasis on regulatory affairs, including one to three years management experience and five years regulatory experience related to assessing need for IND/IDE and FDA submission requirements
  • Relevant certification such as a Certified Clinical Research Professionals (CCRP), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP)
  • Knowledge of clinical trials principles, methodology, guidelines and reporting procedures and standards
  • M.D./D.O., RN, or Ph.D. is preferred

Essential Skills

  • 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 guidelines.
  • 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 Adobe Acrobat.

Preferred Personal Characteristics

  • Passion for excellence and a high level of energy and enthusiasm
  • Capacity to embrace change with an appropriate respect for culture and tradition
  • Demonstrated commitment to diversity
  • Motivator and mentor capable of developing strong teams and developing others
  • Unquestioned personal integrity

Procedure for Candidacy

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 Duchess Johnson, Senior Manager–UAMS Executive Search Group, via email at ejohnson2@uams.edu.

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 compliance.