Live Support, Clinical Research Operations Specialist II
3 weeks ago
The Stanford Center for Clinical Research (SCCR) 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.
SCCR 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. 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 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 a remote position.
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. 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 determining, recommending, and implementing improvements to policies/processes; 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. Clinical research certification from ACRP, SOCRA, or Stanford's CROP.
~ Bachelor’s degree in Clinical Research/Public Health/ Business or related field.
~2 years experience in project management and clinical research projects.
~ Excellent speaking and writing skills.
~ Demonstrated ability to write manuals and procedural documents.
~ Knowledge of Clinical Research Study Startup processes including IRB submissions, site feasibility analyses.
~ 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.
Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
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.
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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.
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.
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, .
Stanford University has five Regional Pay Structures . The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Supporting this mission is our diverse and dedicated 17,000 staff. 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.
We provide superb retirement plans, generous time-off, and family care resources.
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.
The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at stanfordelr@stanford.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
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