Director of Research Regulatory Affairs

Overview

The primary responsibility of the Director of Research Regulatory Affairs is to oversee three sub-departments (Regulatory Unit, Monitoring Unit and Quality Assurance), along with the business administration of ORRA. The Director also directs strategic planning and development of organizational goals and objectives and ensures those goals are accomplished. The Director shall report to the VCRI.

The University of Arkansas for Medical Sciences (UAMS) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving patient care and the lives of Arkansans.

UAMS offers amazing benefits and perks:

• Health: Medical, Dental and Vision plans available for staff and family
• Holiday, Vacation and Sick Leave
• Education discount for staff and dependents (undergraduate only)
• Retirement: Up to 10% matched contribution from UAMS
• Basic Life Insurance up to $50,000
• Career Training and Educational Opportunities
• Merchant Discounts
• Concierge prescription delivery on the main campus when using UAMS pharmacy

Salary: Commensurate to experience

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.
• Other duties as assigned.

Qualifications

Minimum Qualifications:

• 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

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.

UAMS is an Affirmative Action and Equal Opportunity Employer of individuals with disabilities and protected veterans and is committed to excellence. If you need a reasonable accommodation for any part of the employment process, please contact us by telephone at (501) 686-6432 and let us know the nature of your request. We will only respond to messages left that involve a request for a reasonable accommodation in the application process. We will accommodate the needs of any qualified candidate who requests a reasonable accommodation under the Americans with Disabilities Act (ADA).

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 by March 15, 2022 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.

Physical Requirements

Stand: Frequently
Sit: Frequently
Walk: Occasionally
Bend, crawl, crouch, kneel, stoop, or reach overhead: Occasionally
Lift, push, pull, carry weight: 10 lbs or less
Use hands to touch, handle, or feel: Occasionally
Talk: Frequently
Hear: Frequently
Taste or smell: Never
Read, concentrate, think analytically: Continuously
Physical Environment: Inside Medical Facility Environment, Inside Office Environment
Noise Level: Quiet
Visual Requirements: Near visual acuity
Hazards: Biological