Stanford University - Stanford, CA
posted 5 months ago
About the position
The Stanford Center for Clinical Research (SCCR) is seeking a Clinical Research Operations Specialist II to manage a large multi-site clinical trial focused on cardiovascular medicine. This role is pivotal in providing live support to study sites and overseeing the overall management of virtual and multi-site operations. The Clinical Research Operations Specialist II will serve as the primary point of contact for both the study sponsor and the principal investigator (PI). The position emphasizes the importance of effective communication and collaboration, as the specialist will be responsible for addressing time-sensitive requests from study sites, leading efforts in the collection of participant safety data, and reviewing study operations manuals and documents. Additionally, the role includes providing non-urgent support to study sites that may impact enrollment and safety. At SCCR, we prioritize finding team members who are passionate, flexible, and results-oriented. We are committed to equipping our staff with the necessary tools to perform their jobs efficiently while encouraging personal and professional growth. The organization values a healthy work-life balance and provides support to help achieve this balance. If you are eager to make a significant impact through global-reaching clinical research, we invite you to apply for this remote position.
Responsibilities
- Oversee subject recruitment and study enrollment goals, determining effective strategies for promoting and retaining research participants in long-term clinical trials.
- Manage data for research projects, developing systems to organize, collect, report, and monitor data collection, and extracting, analyzing, and interpreting data.
- Develop project schedules, targets, measurements, and accountabilities, leading team meetings and preparing/approving minutes.
- Supervise, train, and mentor new staff or students, including hiring and preparing performance evaluations.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations and implement corrective actions.
- 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.
- Lead efforts to recommend and implement improvements to policies and processes, defining best practices.
- Develop study budgets with staff and principal investigators, tracking patient and study-specific milestones, and invoicing sponsors according to study contracts.
- Ensure ongoing regulatory compliance by regularly inspecting study documents and ensuring Investigational New Drug applications are submitted to the FDA when applicable.
Requirements
- Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
- 2 years of experience in project management and clinical research projects.
- Strong interpersonal skills and proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory bodies, including HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Excellent communication skills, both spoken and written, with the ability to write manuals and procedural documents and give presentations to stakeholders.
- Knowledge of clinical research study startup processes, including IRB submissions and site feasibility analyses.
- Experience developing budgets and supervising, training, and mentoring new staff or students.
Nice-to-haves
- Clinical research certification from ACRP, SOCRA, or Stanford's CROP.
- Strong leadership skills necessary for determining, recommending, and implementing improvements to policies and processes.
Benefits
- Career development programs
- Tuition reimbursement
- Generous time-off
- Family care resources
- Excellent health care benefits
- Free commuter programs
- Ridesharing incentives
- Discounts on various services and products
