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
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
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
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.
THIS IS A REPOST. PREVIOUS APPLICANTS ARE STILL BEING CONSIDERED AND NEED NOT
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
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.
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.
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
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@example.com
Please note: The Office of Human Resources will not be able to provide
specific updates regarding position or application status.
Curriculum Vitae / Resume
Posting Supplemental Questions
Required fields are indicated with an asterisk ().
Have you received training in GCP and ICH Guidelines?
Do you have experience submitting regulatory documents to regulatory bodies (e.g., Institutional Review Boards)?
What are your interests in the field of clinical research?
(Open Ended Question)
Do you have experience drafting informed consent forms?
Please describe your experience with multiple, concurrent projects.
(Open Ended Question)
Please select the response below that best describes your experience/education for the Social/Clinical Research Specialist position.
Bachelor's in a discipline related to the field assigned and at least 1 year of related training or experience.
Associate's, Bachelor's, Master's, Doctorate in an unrelated field and at least 5 years of related training and/or experience.
Master's and/or Doctorate in a discipline related to the field assigned.
Associate's in a discipline related to the field assigned and at least 3 years of related training or experience.
Combination of post-high school education and experience to equal at least 5 years of experience related to the field assigned (ex: 1 year towards a degree and 4 years experience).
Did not complete high school but have a combination of high school education and related experience to equal at least 9 years (ex. 3 years of high school and 6 years of experience).
None of the above