Gene Therapy Clinical Research Coordinator

Medical University of South Carolina; Orleans Estates (SC); On-site; USD 53,000 - 90,000; Full time

Job summary

The Medical University of South Carolina is seeking a Program Coordinator II to manage study-related procedures for patients in Gene Therapy trials. You will oversee IRB submissions, regulatory compliance, budgeting, and contract start-up, while guiding staff in study visits and data handling.

Responsibilities include data collection, entering data into EDC systems, and maintaining logs for consent and safety reporting. Occasional remote work may be possible after orientation.

Qualifications

• Bachelor's degree required with at least three years of relevant program experience.
• Experience coordinating IRB submissions, regulatory documents, and trial start-up.
• Ability to mentor junior staff and coordinate data collection and study visits.

Responsibilities

• Oversee IRB submissions and regulatory requirements across clinical trials.
• Maintain Investigator site files and start-up documentation with budgets and contracts.
• Coordinate data collection, entry into EDC, and query resolution in a timely manner.
• Mentor staff on SOPs, adverse event reporting, and site communications.
• Support gene therapy procedures, patient coordination, and home health logistics.

Skills

IRB submissions

Data entry

Regulatory management

Mentorship

Communication with sponsors

Study coordination

Education

Bachelor's degree

Tools

EDC system

Job description

The Medical University of South Carolina is seeking a Program Coordinator II to manage study-related procedures for patients in Gene Therapy trials. You will oversee IRB submissions, regulatory compliance, budgeting, and contract start-up, while guiding staff in study visits and data handling.

Responsibilities include data collection, entering data into EDC systems, and maintaining logs for consent and safety reporting. Occasional remote work may be possible after orientation.