Job Description:Role Summary:The
Sr. 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.
- Additional responsibilities as assigned to help drive our mission of improving the lives of everyone living with cancer.
Required or Preferred Qualifications:- At least 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 (e.g., Master's, RN, NP) preferred or commensurate experience.
Essential Competencies:- Demonstrated problem-solving and analytical capabilities.
- Knowledge of GCP, ICH guidelines, and regulatory requirements.
- Strong organizational and project management skills.
- Proven track record of leading quality management initiatives, conducting audits and inspections, and driving process improvements.
- Strong communication and interpersonal skills.
- Proven ability to think critically, achieve results and manage tasks while adhering to multiple deadlines both independently and as part of a team.
- High emotional intelligence in partnering with research staff and other subject matter experts.
- Ability to work cross-functionally to deliver on key initiatives.
- Experience working with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other clinical research technologies preferred.
- Ability to adapt to new and changing situations while still maintaining high performance.
- Attendance is an essential job function.
This job description does not contain a full listing of activities, duties or responsibilities required of this role. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.
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