Senior Clinical Trials Operations Lead

OneOncology; United States; On-site; USD 105,000 - 145,000; Full time

Job summary

OneOncology seeks a Sr. Study Operations Specialist to support the successful execution of clinical studies by coordinating and leading various research processes.

You will work closely with investigators, study coordinators, and clinical teams to ensure adherence to protocols and regulatory guidelines and play a key role in patient recruitment and prescreening for enrollment into trials. The role requires collaboration across cross-functional teams, review of patient records for eligibility,

Qualifications

• 5+ years of experience in clinical research, clinical study coordination, or oncology nursing preferred.
• Bachelor's degree in nursing, life sciences, or a 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 regulatory requirements.
• Coordinate patient recruitment across network portfolio.
• Review patient records to determine eligibility for oncology trials.
• Document patient information and screening outcomes in EMR or CTMS.
• Collaborate with healthcare providers, study coordinators, and principal investigators on eligibility and enrollment.
• Stay updated on oncology research and trial methodologies to improve prescreening.
• Work with cross-functional teams to facilitate enrollment and study conduct.
• Ensure data accuracy, completeness, and consistency of study data.
• Facilitate communication between sites, sponsors, CROs, and regulators.
• Identify opportunities for process improvements in clinical study operations.

Skills

Clinical research

Project management

Regulatory knowledge

Data review

Communication

Education

Bachelor's degree in nursing or life sciences

Advanced degree preferred

Tools

EDC systems

CTMS

EMR

Job description

OneOncology seeks a Sr. Study Operations Specialist to support the successful execution of clinical studies by coordinating and leading various research processes.

You will work closely with investigators, study coordinators, and clinical teams to ensure adherence to protocols and regulatory guidelines and play a key role in patient recruitment and prescreening for enrollment into trials. The role requires collaboration across cross-functional teams, review of patient records for eligibility,