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Clinical Research Coordinator 2 - Stanford California
Company: Stanford University Location: Stanford, California
Posted On: 04/26/2024
(SCCR) is a growing academic research organization within the Stanford Department of Medicine (DOM). Our mission is to conduct and promote high-impact, innovative clinical research to improve human health.The Clinical Research Coordinator 2 (CRC2) will work with SCCR in collaboration with the Division of Blood and Marrow Transplantation and Cellular Therapy in DOM and many departments in the School of Medicine. We are a large and growing team with an emphasis on quality, effective operations, and a supportive environment. The Cell Immune Therapy Research Program focuses on stem cell transplantation and cell immunotherapy. Multi-disciplinary collaborations across many departments and divisions create a challenging and rewarding opportunity to engage in Sponsor-Investigator, industry sponsored, and federally sponsored first-in-human research. The CRC2 will help lead and execute study start-up and operations related activities ensuring the clinical research sites readiness to start and execute clinical trials.At SCCR, 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 an onsite position.Duties include: 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 document 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. DESIRED QUALIFICATIONS: Knowledge of FDA regulations, IRB requirements, and Good Clinical Practice.Experience with Word, Excel, Eudora/Outlook, databases, data management and medical terminology.Experience working with health care professionals and clinical research participants.Possess strong organizational skills and a demonstrated ability to work independently with minimal supervision as well as cooperatively in a team environment.Excellent problem-solving skills.Demonstrated proactive approach to developing efficient systems and processes, and addressing barriers.Ability to work effectively with a wide range of individuals and groups at all levels of authority.Proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, exercising sound judgment in setting priorities with a strong attention to detail.Multi-site clinical trial management experience.Project management experience.2-4 years clinical research experience.Study start-up experience.EDUCATION & EXPERIENCE (REQUIRED): 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 (REQUIRED): 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.CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.May require a valid California Driver's License.PHYSICAL REQUIREMENTS: Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.WORKING CONDITIONS: 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.WORKING STANDARDS: |
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