Clinical Research Coordinator II, COVID-19 Hospital
Clinical Research Coordinator II, COVID-19 Hospital🔍School of Medicine, Stanford, California, United States📁Research📅Sep 02, 2020 Post Date📅87207 Requisition #The Stanford Center for Clinical Research (SCCR) is a growing academic research organization within the Stanford Department of Medicine. Our mission is to advance impactful clinical research through quality operations.SCCR is collaborating with Stanford’s Division of Hospital Medicine and Department of Emergency Medicine on a new set of initiatives relating to COVID-19. We are seeking a Clinical Research Coordinator II to launch multiple, globally impactful research projects. You will also help build and strengthen new partnerships in collaboration with a Research Manager and VIPs in the School of Medicine. The CRC2 will conduct clinical research and work independently on progressively more complex projects/assignments. You will also independently manage significant and key aspects of a large study or all aspects of one or more small research studies. This requires an experienced, CRC2 who will work on COVID-19 studies. You will have exceptional communication skills and help build and strengthen new, multidisciplinary partnerships. The CRC2 will develop and launch a new and rapidly growing portfolio of complex clinical research projects relating to COVID-19. You will report to a Clinical Research Manager in SCCR, and work with minimal supervision. 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! 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.
- Graduate degree and/or significant clinical research experience in a hospital setting is a plus.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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.
- 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.
- Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push and pull objects weighing up to ten pounds.
- Occasionally stand, walk, grasp forcefully, use a telephone, write by hand and sort and file paperwork or parts.
- Rarely lift, carry, push and pull objects weighing 11-20 pounds.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
- Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
- A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
- A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
- Discovery and fun. Stroll through historic sculptures, trails, and museums.
- Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Grade: H
- Requisition ID: 87207