Regulatory Affairs Specialist - Oncology (Hybrid Schedule Available)

Roanoke, VA, US, 24011

Employment Status:  Full time
Shift:  Day
Facility:  CASB - Carilion Administrative Services Building
Requisition Number:  129835

Job Summary

The Regulatory Affairs Specialist will support regulatory affairs management for clinical trials at Carilion Clinic in Oncology and other areas, as needed. 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 Manager of Regulatory Affairs, this position is charged with maintaining compliance with study protocols, guidelines set by governing agencies, and institutional policy. Career ladder opportunities are available based on experience, certification, and education.

Candidates Should Possess the Following Qualities:

Collaborative approach to study management
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

Minimum Qualifications

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.


Requisition Number: 129835 
Employment Status: Full time 
Location: CASB - Carilion Administrative Services Building 
Shift: Day 
Shift Details: Flexible Daytime Hours - Hybrid Schedule Available
For more information, contact the HR Service Center at 1-800-599-2537.

Equal Opportunity Employer

Minorities/Females/Protected Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity

Carilion Clinic is a drug-free workplace.


Carilion Total Rewards

What matters to you is important to us—like benefits, rewards, and resources to improve your life. Carilion understands the importance of prioritizing your well-being to help you develop and thrive. When you make your tomorrow with us, we’ll enhance your potential to realize the best in yourself. Below are benefits available to you when you join Carilion:

  • Employer Funded Pension Plan, vested after five years (Voluntary 403B)
  • Comprehensive Medical, Dental, & Vision Benefits
  • Flexible Work Arrangements/Schedules
  • Remote Work Options
  • Paid Time Off (accrued from day one)
  • Onsite fitness studios and discounts to our Carilion Wellness centers
  • Access to our health and wellness app, Virgin Pulse
  • Discounts on childcare
  • Continued education and training

Find more about Carilion Clinic’s benefits by vising our Total Rewards Page.

Equal Opportunity Employer
Minorities/Females/Protected Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity
Carilion Clinic is a drug-free workplace.

Nearest Major Market: Roanoke

Job Segment: Clinical Research, Medical Research, Oncology, ICU, NICU, Healthcare