Soc/Clin Research Specialist - Journey
The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
Position Summary
The UNC LCCC Cellular Therapy Program is seeking a study coordinator to facilitate complex investigational and FDA‑approved cellular and gene therapies in accordance with federal regulations, Good Clinical Practice, and institutional policies. The coordinator will ensure that patients being evaluated for, and undergoing, cell therapy receive comprehensive, coordinated care in a high‑quality manner.
Key responsibilities include:
Designing, developing, and delivering investigational and FDA‑approved cellular and gene therapies to adult and pediatric populations with a multidisciplinary team of pre‑clinical faculty, clinical faculty, and UNC Medical Center staff.
Strategic planning and execution of commercial and research Tumor Infiltrating Lymphocyte (TIL) cell therapies, acting as liaison with oncology, surgical, and pathology teams during tumor tissue procurement and shipment.
Coordinating the conduct of early‑phase cellular and gene therapy clinical trials, including patient and data management.
Maintaining research quality by addressing patient safety and regulatory compliance.
Occasional overtime to support project schedules.
Qualifications
Bachelor’s degree in a relevant discipline and one year of related training or experience (or an equivalent combination of training and experience) from accredited institutions.
Research certification (SOCRA / ACRP) preferred.
Experience in oncology and/or operating room interaction.
Experience with therapeutic clinical research involving drugs and/or devices.
Experience in complex Phase I, II, and III clinical research.
Experience navigating medical records and data extraction.
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.
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The UNC LCCC Cellular Therapy Program is seeking a study coordinator to facilitate complex investigational and FDA‑approved cellular and gene therapies in accordance with federal regulations, Good Clinical Practice, and institutional policies. The coordinator will ensure that patients being evaluated for, and undergoing, cell therapy receive comprehensive, coordinated care in a high‑quality manner.
Key responsibilities include:
Designing, developing, and delivering investigational and FDA‑approved cellular and gene therapies to adult and pediatric populations with a multidisciplinary team of pre‑clinical faculty, clinical faculty, and UNC Medical Center staff.
Strategic planning and execution of commercial and research Tumor Infiltrating Lymphocyte (TIL) cell therapies, acting as liaison with oncology, surgical, and pathology teams during tumor tissue procurement and shipment.
Coordinating the conduct of early‑phase cellular and gene therapy clinical trials, including patient and data management.
Maintaining research quality by addressing patient safety and regulatory compliance.
Occasional overtime to support project schedules.
Qualifications
Bachelor’s degree in a relevant discipline and one year of related training or experience (or an equivalent combination of training and experience) from accredited institutions.
Research certification (SOCRA / ACRP) preferred.
Experience in oncology and/or operating room interaction.
Experience with therapeutic clinical research involving drugs and/or devices.
Experience in complex Phase I, II, and III clinical research.
Experience navigating medical records and data extraction.
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.
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