Regulatory Associate

Job description

Posting Information

Position TypePermanent Staff (SHRA)Is this an internal only recruitment?NoPosition TitleSoc/Clin Research Specialist - JourneyWorking TitleRegulatory AssociatePosition Number20037249, 20001001Vacancy IDP012037Budgeted Hiring Range$53772- $60000Pay Band Information

To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

Salary Grade EquivalentGN11Full-time/Part-time Permanent/Time-LimitedFull-Time PermanentIf time-limited, estimated duration of appointmentHours per week40Work Schedule

Monday – Friday; 8:00 a.m. – 5:00 p.m.

Department Name and NumberLCCC - Clinical Trials-426806Date First Posted10/12/2020Closing Date10/16/2020Position LocationChapel Hill, NCPosition Posting CategoryResearch ProfessionalsDepartment 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.

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

UNC Lineberger Comprehensive Cancer Center’s Clinical Protocol Office is recruiting for 2 Social/Clinical Research Specialist (Regulatory Associate) positions. By applying to this posting you will be considered for both positions: 20037249 and 20001001.

This position 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

Requires sitting for extended periods of time. Ability to move 25 pounds. Ability and willingness to push cart with files between 4-5 buildings.

Position/Schedule RequirementsPosition AttributesStimulus/ARRA FundedNoQuick Link 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.

Applicant DocumentsRequired Documents
  1. Curriculum Vitae / Resume
  2. Cover Letter
Optional Documents
    Posting Supplemental Questions

    Required fields are indicated with an asterisk (*).

    1. * 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
    2. * Have you received training in GCP and ICH Guidelines?
      • yes
      • no
    3. * Do you have experience submitting regulatory documents to regulatory bodies (e.g., Institutional Review Boards)?
      • yes
      • no
    4. * What are your interests in the field of clinical research?

      (Open Ended Question)

    5. * Do you have experience drafting informed consent forms?
      • yes
      • no
    6. * Please describe your experience with multiple, concurrent projects.

      (Open Ended Question)




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    Job No:
    Posted: 10/13/2020
    Application Due: 10/18/2020
    Work Type: