Clinical Data Management Associate

University of North Carolina- Chapel Hill

United States

August 17, 2022

Description

Posting Information

Posting Information

Department LCCC - Clinical Trials-426806

Career Area Research Professionals Is this an internal only recruitment? No Posting Open Date 07/11/2022 Application Deadline 08/17/2022 Position Type Permanent Staff (SHRA) Position Title Soc/Clin Research Specialist - Journey Salary Grade Equivalent GN11 Working Title Clinical Data Management Associate Position Number 20030745 Vacancy ID P015552 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.

Work Location Chapel Hill, NC Position Location North Carolina, US Hiring Range $53,772 - $65,000 Pay Band Information

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

Position Summary Information

Primary Purpose of Organizational Unit

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service. OUR VISION Our vision is to be the nation's leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding. OUR MISSION Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond. Education: We will prepare tomorrow's health care professionals and biomedical researchers by facilitating learning within innovative curricula and team- oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce. Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

Position Summary

The Clinical Data Management Associate conducts clinical data management activities on oncology clinical research data collected for investigator- initiated trials sponsored by the UNC Lineberger Comprehensive Cancer Center. The primary duties involve quality oversight of multiple clinical trials, including developing and maintaining Data Management Plans, Data Validation Plans, Form Completion Guidelines, and other instructions; conducting study-specific testing and validation of electronic Case Report Forms; comprehensive quality oversight of data collection; extraction of data and reporting; consultation with investigators; and training of study teams in study data management.

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.

Required Qualifications, Competencies, and Experience

Knowledge of clinical trial design; clinical research principles as defined by Code of Federal Regulations including Good Clinical Practices (GCP) 21 CFR Parts 50, 54, 56, 312, 314 along with ICH Guidelines and Health Insurance Portability and Accountability Act (HIPAA) regulations pertinent to research; clinical trials management and electronic data capture systems. Demonstrated ability to implement data and information collection. Demonstrated ability to analyze data/information for accuracy, validity, and integrity; the ability to maintain quality control and assurance; the ability to apply criteria or parameters for extract of data/information; the ability to interpret and evaluate results; and the ability to prepare reports and/or presentations. Demonstrated ability to provide consultation and instruction.

Preferred Qualifications, Competencies, and Experience

Masters degree preferred.

Required Licenses/Certifications Special Physical/Mental Requirements Campus Security Authority Responsibilities

Not Applicable.

Position/Schedule Requirements Overtime occasionally Special Instructions Quick Link https: // unc.peopleadmin.com/postings/235083

Contact Information

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 employment@unc.edu

Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

Equal Opportunity Employer Statement

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.

Applicant Documents

Required Documents

  • Curriculum Vitae / Resume
  • Cover Letter
  • List of References
  • Optional Documents

    Posting Supplemental Questions

    Required fields are indicated with an asterisk ().

  • 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
  • Please describe your experience maintaining quality control and quality assurance.
  • (Open Ended Question)

  • Do you have knowledge of clinical research principles as defined by the Code of Federal Regulations and ICH GCP?
  • Yes
  • No
  • Do you experience with electronic data capture systems?
  • Yes
  • No
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