The Stanford Center for Clinical Research (CRH) is a growing academic research organization within the Stanford Department of Medicine. Our mission is to conduct and promote high-impact, innovative clinical research to improve human health.
CRH is seeking a Clinical Research Operations Specialist II to conduct and manage a large multi-site clinical trial. Research will be conducted in cardiovascular medicine. The Clinical Research Operations Specialist II will be responsible for providing study sites with live support and the overall site management of virtual and multisite operations. This position will be the main point of contact for the study sponsor and the study PI.
In addition to the core duties described below, this position will be responsible for the following: a) providing study sites with live support for time-sensitive requests; b) leading efforts in collection of participant safety data; b) reviewing study Operations Manuals and Documents; and c) providing non-urgent support to study sites that impact enrollment and safety.
At CRH, we strive to find team members who are passionate about their work, flexible, fun, and want to deliver results. We place a high priority on equipping our staff to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team to have a healthy balance between work commitments and life outside of work and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research, we encourage you to apply!
This is a remote position.
Core Duties
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
- Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
- Formally supervise, train, and/or mentor new staff or students, as assigned, 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; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
- 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; define 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 inspect 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.
Minimum Education and Experience
Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
Knowledge, Skills and Abilities
- Strong interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Drivers License Requirements
- Must possess and maintain a valid California non-commercial Class C Driver’s License.
- Ability to drive day or night.
- When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.