Regulatory Affairs Specialist - Inpatient (Hybrid Schedule Available)

How You’ll Help Transform Healthcare:

Regulatory Affairs Specialist - Inpatient Clinical Trials Unit (Hybrid)
The Regulatory Affairs Specialist will support regulatory affairs management for clinical trials taking place within the newly developed inpatient clinical trials unit at Carilion Clinic. Basic responsibilities include supporting research investigators/physicians with guidance on research policies and processes, enabling successful collaborations with research sponsors, interfacing with both internal and external Institutional Review Boards, and monitoring and tracking study progress.
Under the supervision of the Regulatory Affairs Manager, this position is charged with maintaining compliance with study protocols, guidelines set by governing agencies, and institutional policy. 

Candidates Should Possess the Following Qualities:

Detail-oriented
Collaborative approach to study management
Organized
Comfortable in a fast-paced environment
Able to balance multiple priorities
Motivated by challenges
Driven by Carilion Clinic's mission to improve the health of the communities we serve

What We Require:

Education: Bachelor’s degree required.

Experience: Preferred - 1 year in healthcare or research or experience working with an IRB.

Licensure, certification, and/or registration: clinical research certification through SoCRA or ACRP is required as soon as eligibility requirements are met.

Other Minimum Qualifications: Knowledge of medical terminology desired. Must be competent in word processing and spreadsheets. Knowledgeable about data base management systems. Must have effective interpersonal and problem-solving skills. Must be self-directed and excel in attention to detail. Must use good judgment with regard to priorities and deadlines. Candidates must have excellent writing skills in order to generate reports, forms, correspondence.

About Carilion

This is Carilion Clinic ...

An organization where innovation happens, collaboration is expected and ideas are valued. A not-for-profit, mission-driven health system built on progress and partnerships. A courageous team that is always learning, never discouraged and forever curious.

Headquartered in Roanoke, Va., you will find a robust system of award winning hospitals, Level 1 and 3 trauma centers, Level 3 NICU, Institute of Orthopedics and Neurosciences, multi-specialty physician practices, and The Virginia Tech Carilion School of Medicine and Research Institute.

Carilion is where you can make your own path, make new discoveries and, most importantly, make a difference. Here, in a place where the air is clean, people are kind and life is good. Make your tomorrow with us.