Regulatory Specialist II

University of Arkansas System • Little Rock, AR

1d

About The Position

Position will be directly responsible for 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. Workload will consist of industry-sponsored, foundation/private non-profit-sponsored, and investigator-initiated clinical trials. Position must be able to organize complex projects, provide attention to detail, and communicate effectively. Will 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. Position maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. The employee will work directly with pharmaceutical company sponsors, institutional investigators, and research staff.

Requirements

• Bachelor's degree plus 3 years of experience OR High School, GED, or formal education equivalent plus 7 years of research experience in lieu of bachelor’s degree
• Bachelor's Degree plus 3 years clinical research experience with demonstrated experience/proficiency in one or more of the following functional areas as relevant to clinical trials: study planning/development, regulatory start-up, regulatory maintenance and reporting from study activation to closeout; or High School plus 7 years' experience as listed above

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
• Organizing complex projects
• Providing attention to detail
• Communicating effectively
• Applying knowledge of local policies and federal regulations and guidelines in support of an assigned clinical trial portfolio and the objectives of TRI
• Contributing information and ideas related to areas of responsibility as part of a cross functional team
• Ensuring effective and efficient workflow and adherence to quality standards for staff/program and self
• Maintaining a working knowledge of the Code of Federal Regulations and the code of conduct for human research
• Working directly with pharmaceutical company sponsors, institutional investigators, and research staff

Benefits

• Medical, Dental and Vision plans available for qualifying staff and family
• Holiday, Vacation and Sick Leave
• Education discount for staff and dependents (undergraduate only)
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level