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Clinical Research Operations Specialist II
2 months ago
Job Summary:
Stanford University is seeking a highly skilled Clinical Research Operations Specialist II to join our team. This role will be responsible for providing live support to study sites and managing virtual and multisite operations.
Key Responsibilities:
- Oversee subject recruitment and study enrollment goals, determining effective strategies for promoting and recruiting research participants and retaining participants in long-term clinical trials.
- Oversee data management for research projects, developing and managing systems to organize, collect, report, and monitor data collection, extracting, analyzing, and interpreting data.
- Develop project schedules, targets, measurements, and accountabilities, leading team meetings and preparing/approving minutes.
- Formally supervise, train, and/or mentor new staff or students, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations, providing leadership in identifying and implementing corrective actions/processes.
- Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
- Provide leadership in determining, recommending, and implementing improvements to policies/processes, defining best practices.
- Develop study budget with staff and principal investigator, identifying standard of care versus study procedures, track patient and study specific milestones, and invoice sponsors according to study contract.
- Ensure regulatory compliance, regularly inspecting study documents to ensure ongoing regulatory compliance.
- Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable, ensure Institutional Review Board renewals are completed.
Requirements:
- Bachelor's degree in Clinical Research/Public Health/Business or related field.
- Two years of experience in project management and clinical research projects.
- Excellent communication skills.
- Excellent speaking and writing skills.
- Demonstrated ability to write manuals and procedural documents.
- Demonstrated ability to give presentations to stakeholders.
- Knowledge of Clinical Research Study Startup processes including IRB submissions, site feasibility analyses.
- Experience developing budgets.
- Experience supervising, training, and/or mentoring new staff or students.
- Strong leadership skills necessary for determining, recommending, and implementing improvements to policies/processes and best practices.
Preferred Qualifications:
- Clinical research certification from ACRP, SOCRA, or Stanford's CROP.
Working Conditions:
This position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
May require extended or unusual work hours based on research requirements and business needs.
