Oncology IIT Start-Up Lead & Protocol Writer

Medical University of South Carolina; Orleans Estates (SC); On-site; USD 68,000 - 122,000; Full time

Job summary

The Medical University of South Carolina is seeking an experienced program coordinator to oversee the activation of investigator-initiated oncology trials within the Hollings Cancer Center IIT portfolio, ensuring GCP compliance and regulatory submissions across participating sites.

Reporting to the SISU Administrative Director and the HART Scientific Director, you will manage study documents, startup activities, and collaboration with principal investigators, biostatisticians, and external

Qualifications

• Bachelor's degree is required; three years relevant program experience preferred.

Responsibilities

• 35% HCC investigator Trial Concept Support: manage intake of new IIT concepts, coordinate with stakeholders, prepare protocol documents and regulatory materials.
• 35% HCC Investigator-Initiated Trial Activation: complete FDA/IRB applications, coordinate with PI and CTO team, ensure activation per GCP and CFR.
• 20% HCC IIT Amendments: process protocol/regulatory amendments, track versions, submit to IRB/FDA as needed.
• 10% Administrative Support: minutes, scheduling, document preparation, assist in program initiatives.

Education

Bachelor's degree

Job description

The Medical University of South Carolina is seeking an experienced program coordinator to oversee the activation of investigator-initiated oncology trials within the Hollings Cancer Center IIT portfolio, ensuring GCP compliance and regulatory submissions across participating sites.

Reporting to the SISU Administrative Director and the HART Scientific Director, you will manage study documents, startup activities, and collaboration with principal investigators, biostatisticians, and external