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 Regulatory Affairs
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 institutional regulations.
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.
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 Professional (CIP)
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 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.