Senior Clinical Research Coordinator, Surgical Oncology

University of Louisville; Aurora (CO); Sur place; USD 75 000 - 95 000; Plein temps

Résumé du poste

University of Louisville’s Department of Surgical Oncology seeks a Clinical Research Coordinator V to oversee enrollment, accrual and coordination of daily clinical trials activities. The role collaborates with investigators, sponsors, monitors and regulatory bodies to ensure safety and efficient operations.

The position emphasizes regulatory compliance (IRB/FDA/OHRP), accurate data management, and timely study completion, with compensation commensurate to experience.

Qualifications

• Bachelor’s degree in a related field and two (2) or more years of relevant research experience, or an equivalent combination of education and work experience.
• Equivalency of education and work experience is accepted.
• Grade 5 (Salaried)

Responsabilités

• Coordinates the activation, implementation, enrollment, accrual, and maintenance of multiple research protocols.
• Ensures assigned studies are conducted in accordance with UL IRB, FDA and OHRP.
• Ensures site compliance with research protocols by reviewing regulatory requirements.
• Assists investigators and clinical staff in recruitment, screening and enrollment of eligible participants.
• Develops accurate source materials and ensures compliance from site staff.
• Provides data collection, documentation, data entry and reporting in accordance with SOPs and regulations.
• Interfaces with research participants to determine eligibility and consent.
• Communicates study requirements to study participants and teams.
• Provides ongoing quality control of study operations including accountability logs.

Connaissances

Regulatory coordination

Clinical research experience

Enrollment and accrual

Formation

Bachelor’s degree in a related field

2+ years of relevant research experience

Description du poste

University of Louisville’s Department of Surgical Oncology seeks a Clinical Research Coordinator V to oversee enrollment, accrual and coordination of daily clinical trials activities. The role collaborates with investigators, sponsors, monitors and regulatory bodies to ensure safety and efficient operations.

The position emphasizes regulatory compliance (IRB/FDA/OHRP), accurate data management, and timely study completion, with compensation commensurate to experience.