Remote Senior Clinical Trials Operations Lead

Astera Cancer Care; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

OneOncology is seeking a Sr. Study Operations Specialist to support successful execution of clinical studies by coordinating multiple research processes and leading enrollment activities.

You will work closely with investigators, study coordinators and regulatory staff to ensure adherence to protocols, GCP and ICH guidelines, and accurate documentation in EMR and CTMS. The role emphasizes patient prescreening, cross-functional collaboration, and staying current with oncology trial developments

Qualifications

• 5+ years in clinical research, clinical study coordination, or oncology nursing preferred.
• Bachelor's degree in nursing, life sciences, or related field; advanced degree preferred.
• Knowledge of GCP/ICH guidelines and regulatory requirements.

Responsibilities

• Assist in planning, implementation, and management of clinical studies, including enrollment, follow-up, and close-out.
• Ensure studies adhere to protocols, GCP/ICH guidelines, and regulatory requirements.
• Coordinate patient recruitment activities across the network portfolio.
• Review patient records to determine eligibility for oncology studies.
• Document patient information and screening outcomes in EMR or CTMS.
• Collaborate with clinicians, study coordinators, and investigators on eligibility and enrollment.

Skills

Problem solving

Analytical skills

Organizational skills

Communication

Cross-functional collaboration

Emotional intelligence

Deadline management

Education

Bachelor's degree in nursing or life sciences

Advanced degree (e.g., Master's, RN, NP) preferred

Tools

EDC systems

CTMS

EMR systems

Job description

OneOncology is seeking a Sr. Study Operations Specialist to support successful execution of clinical studies by coordinating multiple research processes and leading enrollment activities.

You will work closely with investigators, study coordinators and regulatory staff to ensure adherence to protocols, GCP and ICH guidelines, and accurate documentation in EMR and CTMS. The role emphasizes patient prescreening, cross-functional collaboration, and staying current with oncology trial developments