Senior Assistant Study Coordinator

UNC-Chapel Hill; Chapel Hill (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

UNC-Chapel Hill's LCCC Cellular Therapy Program seeks a Clinical Data Manager to support early-phase adult and pediatric trials in cellular and gene therapy. The role emphasizes regulatory compliance, data abstraction, query resolution, and data quality across multiple trial protocols.

The incumbent will manage data entry, perform QC, coordinate with study teams, and ensure alignment with federal guidelines and local policies.

Qualifications

• Clinical trial data management experience preferred.
• Experience with data abstraction and review.
• Familiarity with regulatory requirements (GCP/ICH).
• SOCRA/ACRP certification is advantageous.

Responsibilities

• Support complex, early-phase cellular and gene therapy trials by managing clinical data.
• Enter data, perform quality checks, and resolve data queries.
• Serve as primary point of contact for program data entry activities.

Skills

Clinical data management

Oncology trials

Data query & resolution

SOCRA/ACRP credential

Education

Bachelor's degree

Job description

Full-time/Part-time Permanent/Time-Limited

Full-time/Part-time Permanent/Time-Limited Full-Time Permanent

If time-limited, estimated duration of appointment

This position is not eligible for H‑1B sponsorship.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC -Chapel Hill offers full‑time employees a comprehensive benefits package , paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

Primary Purpose of Organizational Unit

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 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 prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team‑oriented interprofessional education to ensure a highly skilled workforce.

Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.

Position Summary

UNC LCCC Cellular Therapy Program (https://unclineberger.org/cellular-immunotherapy/) is one of the select few academic centers in the United States with the scientific, technical and clinical capabilities to identify new tumor targets and develop and infuse novel CAR -T immunotherapy. The purpose of this position is to provide clinical data management support for the program’s complex, early‑phase adult and pediatric cellular and gene therapy clinical trials and to ensure that clinical data management activities are conducted according to federal regulations, Good Clinical Practice, and local and institutional policies. This position is responsible to clinical data abstraction and review, query resolution and reconciliation to support the delivery of clinical data. This position will be responsible for data entry activities, quality control review, identification, and documentation of data problems during EDC tracking and maintenance and serve as the primary contact for data entry activities for the program.

Minimum Education and Experience Requirements

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

Management Preferences

• Clinical trial experience in oncology.
• Previous experience with early‑phase therapeutic clinical research involving drugs and/or devices.
• Experience navigating medical records and data extraction.
• Research Certification – SOCRA / ACRP

Equal Opportunity Employer Statement

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.

Required Documents

• Curriculum Vitae / Resume
• Cover Letter
• 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 GCP and ICH Guidelines?
  • Yes
  • No
• * Please describe your experience with oncology clinical trials.

  (Open Ended Question)

• * Please describe your experience with data query and resolution.

  (Open Ended Question)