Sr. Study Operations Specialist

OneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.

Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.

Job Description:

The Senior Study Operations Specialist is responsible for supporting the successful execution of clinical studies by coordinating and leading various aspects of the research process. This role works closely with investigators, study coordinators, and clinical teams to ensure studies are conducted in adherence to protocols and regulatory guidelines. In addition, the Sr. Study Operations Specialist plays a key role in patient recruitment and prescreening to ensure eligible participants are identified and communicated to the network practice for enrollment into clinical studies. 

Responsibilities  

• Assist in the planning, implementation, and management of clinical studies, including study enrollment, follow-up, and close-out. 

• Ensure clinical studies are conducted in compliance with study protocols, GCP, ICH guidelines, and local regulatory requirements. 

• Coordinate patient recruitment activities across network portfolio. 

• Review patient records to determine eligibility for participation in oncology clinical studies.  

• Accurately document patient information and screening outcomes in electronic medical records (EMR) or clinical trial management systems (CTMS). 

• Collaborate with healthcare providers, study coordinators, and principal investigators to discuss patient eligibility, screening results, and potential trial enrollment. 

• Stay updated on advances in oncology research, clinical trial methodologies, and relevant therapeutic areas to enhance prescreening effectiveness. 

• Work collaboratively with cross-functional teams, including clinicians, research staff, and regulatory affairs personnel, to facilitate seamless patient enrollment and study conduct. 

• Ensure the accuracy, completeness, and consistency of study data. 

• Facilitate communication between study sites, sponsors, CROs, and regulatory authorities to ensure smooth study operations. 

• Identify opportunities for process improvements in clinical study operations and implement best practices to enhance study quality and efficiency. 

• Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer. 

Key Competencies  

• Demonstrated problem-solving and analytical capabilities.  

• Knowledge of GCP, ICH guidelines, and regulatory requirements. 

• Strong organizational and project managem