Regulatory Affairs Specialist I jobs in United States
cer-icon
Apply on Employer Site
company-logo

UAMS - University of Arkansas for Medical Sciences · 6 hours ago

Regulatory Affairs Specialist I

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. The Regulatory Affairs Specialist I will be responsible for ensuring regulatory compliance and administrative management for multiple clinical trials, collaborating with various stakeholders to maintain adherence to quality standards.

EducationHealth CareNon Profit
badNo H1Bnote

Responsibilities

Ensuring regulatory compliance and administrative management for multiple clinical trials
Working closely with investigators, industry sponsors, contract research organization representatives, and UAMS institutional oversight offices
Organize complex projects
Provide attention to detail
Communicate effectively
Apply knowledge of local policies and federal regulations and guidelines in support of an assigned clinical trial portfolio and the objectives of TRI
Contributes information and ideas related to areas of responsibility as part of a cross functional team
Ensures effective and efficient workflow and adherence to quality standards for staff/program and self
Maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research
Work directly with pharmaceutical company sponsors, institutional investigators, and research staff

Qualification

Clinical researchFDA Regulatory AffairsCRS certificationAttention to detailEffective communication

Required

Bachelor's degree plus 1 year of experience in clinical research and/or FDA Regulatory Affairs OR High School Diploma, GED, or formal education equivalent plus five (5) years of general research or similar experience
Obtain CRS certification within 2 years of hire

Preferred

Proof of Veteran Status

Benefits

Health: Medical, Dental and Vision plans available for qualifying 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

Company

UAMS - University of Arkansas for Medical Sciences

company-logo
UAMS is the state’s only comprehensive academic health center, with colleges of Medicine, Nursing, Pharmacy, Health Professions and Public Health; a graduate school; a hospital; a northwest Arkansas regional campus; a statewide network of regional centers; and seven institutes: the Winthrop P.

Funding

Current Stage
Late Stage
Total Funding
$5.65M
Key Investors
National Institute of Allergy and Infectious DiseasesNational Cancer Institute
2023-03-16Grant· $1M
2022-08-25Grant· $3.4M
2022-06-23Grant· $1.25M

Leadership Team

leader-logo
Amanda George
Vice Chancellor for Finance & Chief Financial Officer
linkedin
leader-logo
Christina Clark
Chief Operating Officer
linkedin
Company data provided by crunchbase