Senior Clinical Research Coordinator: Reg & Data Lead

Lurie Children's Hospital; Chicago (IL); Presencial; USD 59.000 - 97.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental and vision coverage

403(b) retirement plan with employer

Paid time off and holidays

Professional development support

Descripción de la vacante

Lurie Children’s Hospital seeks an experienced research coordinator to oversee clinical studies, ensuring regulatory compliance and ethical conduct. The role involves coordinating start-up, monitoring, and close-out visits, managing regulatory submissions, and leading data handling and QA processes.

You will work with investigators to recruit participants, manage budgets, and support grant preparation while mentoring junior staff in a collaborative environment.

Formación

• Bachelor’s degree and two or more years research experience required.
• Two-three years with complex research projects preferred.
• Strong organizational, verbal and written communication skills.
• Strong knowledge of FDA, HSR, and GCP Guidelines.
• Analytical skills for quantitative and qualitative methods.
• May assist in technology system implementation and data handling.

Responsabilidades

• Coordinates and oversees all aspects of clinical research projects from start-up to close-out.
• Oversees site visits, addresses sponsor queries, ensures adherence to protocols.
• Manages regulatory documents, submissions, SOPs and study registrations as needed.
• Promotes ethical conduct and data integrity in all study activities.
• Manages logistics, inventory, lab kits, and study documentation.
• Engages participants, conducts consent processes, and coordinates reimbursements.

Conocimientos

Regulatory compliance

FDA guidelines

GCP guidelines

Data management

Project coordination

Leadership

Educación

Bachelor’s degree in Biomedical Science

Herramientas

ClinicalTrials.gov

Descripción del empleo

Lurie Children’s Hospital seeks an experienced research coordinator to oversee clinical studies, ensuring regulatory compliance and ethical conduct. The role involves coordinating start-up, monitoring, and close-out visits, managing regulatory submissions, and leading data handling and QA processes.

You will work with investigators to recruit participants, manage budgets, and support grant preparation while mentoring junior staff in a collaborative environment.