Remote Senior Study Operations Lead

OneOncology; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

OneOncology is seeking a Sr. Study Operations Specialist to coordinate and lead clinical studies, ensuring adherence to protocols and regulatory guidelines while supporting patient recruitment across the network.

You will collaborate with investigators, study coordinators, and clinical teams, manage data in EMR/CTMS, and drive process improvements to enhance study quality and efficiency. Ideal candidates typically have 5+ years in clinical research with a nursing or life sciences background;

Qualifications

• 5+ years of experience in clinical research, study coordination, or oncology nursing preferred.
• Bachelor's degree in nursing, life sciences, or related field; advanced degree preferred or commensurate experience.

Responsibilities

• Assist in planning, implementation, and management of clinical studies including enrollment, follow-up, and close-out.
• Ensure studies comply with protocols, GCP, ICH guidelines, and local regulations.
• Coordinate patient recruitment across network portfolio.
• Review records to determine eligibility for oncology trials.
• Document patient information and screening outcomes in EMR/CTMS.
• Collaborate with clinicians, coordinators, and investigators on eligibility and enrollment.
• Stay updated on oncology research and trial methodologies to enhance prescreening.
• Work with cross-functional teams to facilitate enrollment and study conduct.
• Ensure data accuracy, completeness, and consistency.
• Facilitate communication between sites, sponsors, CROs, and regulators.
• Identify opportunities for process improvements in study operations.

Skills

Clinical research

GCP knowledge

Project management

Quality improvement

Cross-functional collaboration

Communication

Education

Bachelor's degree in nursing or life sciences

Advanced degree preferred

Tools

EMR

CTMS

EDC systems

Job description

OneOncology is seeking a Sr. Study Operations Specialist to coordinate and lead clinical studies, ensuring adherence to protocols and regulatory guidelines while supporting patient recruitment across the network.

You will collaborate with investigators, study coordinators, and clinical teams, manage data in EMR/CTMS, and drive process improvements to enhance study quality and efficiency. Ideal candidates typically have 5+ years in clinical research with a nursing or life sciences background;