Regulatory Associate

University of North Carolina, United States

Updated: over 2 years ago
Location: Chapel Hill, NORTH CAROLINA
Job Type: FullTime
Deadline: ; ;

Posting Information


Position Type Permanent Staff (SHRA)
Is this an internal only recruitment? No
Position Title Soc/Clin Research Specialist - Journey
Working Title Regulatory Associate
Position Number 20038061, 20038062
Vacancy ID P012522
Budgeted Hiring Range $53,772 - $60,000
Pay Band Information
To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet .
Salary Grade Equivalent GN11
Full-time/Part-time Permanent/Time-Limited Full-Time Permanent
If time-limited, estimated duration of appointment
Hours per week 40
Work Schedule
Monday – Friday; 8:00 a.m. – 5:00 p.m.
Department Name and Number LCCC - Clinical Trials-426806
Date First Posted 03/26/2021
Closing Date 08/02/2021
Position Location Chapel Hill, NC
Position Posting Category Research Professionals

Department Description
The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is a National Cancer Institute (NCI)-designated comprehensive cancer center. The Center’s mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach. 
 
UNC Lineberger’s Clinical Protocol Office (CPO) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The Protocol Office is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.
Equal Opportunity Employer
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
Position Description
THIS IS A REPOST. PREVIOUS APPLICANTS ARE STILL BEING CONSIDERED AND NEED NOT REAPPLY. 
 
UNC Lineberger’s Clinical Protocol Office (CPO) is recruiting for two Regulatory Associates. By applying to this recruitment you will be considered for both positions: 20038061 and 20038062. 
 
The Regulatory Associate is responsible for regulatory compliance of an assigned disease group(s) which includes providing regulatory guidance and training to investigators and CPO staff; preparing and submitting required regulatory documents and responses to regulatory bodies (e.g., Institutional Review Boards (IRB)); and creating and maintaining professional working relationships with investigators, sponsors, team members, and others. These responsibilities relate to the UNC/LCCC CPO mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.
Minimum Education and Experience Requirements
Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Essential Skills, Knowledge and Abilities
Demonstrated ability to provide consultation and lead exchange of research information through technical assistance and instruction. Demonstrated ability to train others, including documenting steps needed to collect information and to independently provide consultation to sites or others related to the specific protocols and regulatory guidance. Demonstrated ability to write comprehensive reports summarizing results and conveying to supervisory personnel. Demonstrated ability to plan work to meet objectives and deadlines.
Preferred Qualifications
Significant use of information technology is expected for this position. Experience in clinical research preferred, including familiarity with CFR Parts 50, 54, 56, 312, 314 and ICH Guidelines. CCRP, CCRC, CIRB or RAC Certification preferred. A cover letter is encouraged as an example of professional written communication skills. Master’s degree or higher preferred. CCRP, CCRC, CIRB or RAC Certification preferred.
Required Licenses/Certifications
Special Physical and Mental Requirements
Ability to lift/move 25 pounds and ability to move cart with files between 4-5 buildings with or without accommodation.
Position/Schedule Requirements Evening work occasionally, Weekend work occasionally
Position Attributes
Stimulus/ARRA Funded No
Quick Link https://unc.peopleadmin.com/postings/190124

Office of Human Resources Contact Information
If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to [email protected] 
 
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

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