DSM Coordinator

University of North Carolina- Chapel Hill

United States

December 3, 2021

Description

Posting Information Department LCCC - Clinical Trials-426806

Career Area Research Professionals Is this an internal only recruitment? No Posting Open Date 11/10/2021 Application Deadline 12/03/2021 Position Type Permanent Staff (SHRA) Position Title Soc/Clin Research Assistant - Advanced Salary Grade Equivalent GN10 Working Title DSM Coordinator Position Number 00059786 Vacancy ID P013888 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, 8:00AM – 5:00PM

Work Location Chapel Hill, NC Position Location North Carolina, US Hiring Range $48,008 - $59,900 Pay Band Information

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

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

This position provides support for the critical functions of the Data and Safety Monitoring Committee (DSMC) for the Lineberger Clinical Protocol Office. As an NCI designated Cancer Center, LCCC is expected to convene a DSMC for safety review and quality oversight of clinical trials conducted at LCCC. The DSMC Coordinator will extract study enrollment details, safety reports, protocol deviations and other information from the oncology databases (e.g., OnCore) for DSMC review. The coordinator runs the internal DSMC meeting every 2 weeks and the DSMC Blue monthly meeting comprised of external reviewers from other academic sites.

Additional duties include participation in process improvement initiatives, including recommending and implementing changes to processes as needed, assisting with the monitoring of cooperative group charts and facilitating monitoring reports (including design of systems to organize and distribute queries to relevant staff), follow-up to ensure compliance, and training staff to appropriately. This position is a member of the Compliance Committee.

Minimum Education and Experience Requirements

Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Required Qualifications, Competencies, and Experience

Excellent communication and organizational skills Knowledge of Code of Federal Regulations and Good Clinical Practice Parts 50, 54, 56, 312, 314. Knowledge of clinical research principles as defined by Code of 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 such as OnCore. Demonstrated ability to collect data and provide reports using information technology systems, compiled data, and reported outcomes. Demonstrated ability to establish goals, objectives, and excellent management of timelines Demonstrated ability to review data for accuracy, and provide meaningful feedback to address discrepancies, suggested corrective actions and training needs Demonstrated ability to provide and organize reports and data, advanced writing and editing skills, and strong attention to detail Demonstrated ability to facilitate development of complete processes and procedures

Preferred Qualifications, Competencies, and Experience

Certification, such as RN, MT, PA, RPh, RT, or QARC 3 – 5 years of experience in clinical research Experience in Quality Assurance

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/215466

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
  • Optional Documents

  • List of References
  • 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 Assistant position.
  • Bachelor's, Master's, and/or Doctorate in any field.
  • Associate's in any field and at least 2 years of experience.
  • Combination of post-high school education and experience to equal at least 4 years of related experience (ex: 1 year towards a degree and 3 years of experience).
  • High School diploma/GED and at least 4 years of related experience.
  • Did not complete high school but have a combination of high school education and experience to equal 8 years. (ex. 3 years of high school and 5 years of experience).
  • None of the above
  • Do you have knowledge of Code of Federal Regulations and Good Clinical Practice Parts 50, 54, 56, 312, 314?
  • yes
  • no
  • Do you have research data collection experience?
  • (Open Ended Question)

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