Study Start up Specialist

The BMT program at Stanford performs autologous and allogeneic transplantations for over 300 patients each year. The program has been very successful with a history of limited morbidity rates and acute mortality that is well below most published reports. In addition to a successful clinical practice, our program researchers are translating their discoveries into new therapies, advancing the efficacy of hematopoietic cell transplantation for patients worldwide.

The Study Start up (SSU) Specialist will work with the Division of Blood and Marrow Transplantation and Cellular Therapy in DOM and the Department of Surgery - Division of Abdominal Transplantation and partners in the Stanford Center for Clinical Research (SCCR). 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. SSU Specialist will lead and execute all SSU-related activities ensuring the clinical research sites readiness to start the clinical trials.

This requires an experienced clinical research professional who will work in a hybrid role. You will have exceptional communication skills and help build and strengthen new, multidisciplinary partnerships. The SSU Specialist will develop and launch a new and rapidly growing portfolio of complex clinical research projects relating to cellular immune tolerance. You will report to a Clinical Research Portfolio Manager in BMT, and work with minimal supervision.

Duties include:

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• Develop strategy and workflow for all study start-up activities.
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• Assist in development of effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
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• Assist in data management workflow development for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
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• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
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• 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.
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• 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.
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• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
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• Provide leadership in determining, recommending, and implementing improvements to policies/processes. define best practices.
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• 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.
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• Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.
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• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
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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. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

DESIRED QUALIFICATIONS:

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• Knowledge of FDA regulations, IRB requirements, and Good Clinical Practice.
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• Experience with Word, Excel, Eudora/Outlook, databases, data management and medical terminology.
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• Experience working with health care professionals and clinical research participants.
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• Possess strong organizational skills and a demonstrated ability to work independently with minimal supervision as well as cooperatively in a team environment.
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• Excellent problem-solving skills.
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• Demonstrated proactive approach to developing efficient systems and processes, and addressing barriers.
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• Ability to work effectively with a wide range of individuals and groups at all levels of authority.
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• 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.
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• Multi-site clinical trial management experience.
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• Project management experience.
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• 2-4 years clinical research experience.
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• Study start-up experience.
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• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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EDUCATION & EXPERIENCE (REQUIRED):

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• Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
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KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

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• Strong interpersonal skills.
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• Proficiency in Microsoft Office and database applications.
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• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
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• Knowledge of medical terminology.
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CERTIFICATIONS & LICENSES:

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• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. May require a valid California Driver's License.
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PHYSICAL REQUIREMENTS:

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• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
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• 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.
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• 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.
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Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

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• 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.
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• May require extended or unusual work hours based on research requirements and business needs.
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WORKING STANDARDS:

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• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
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• 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.
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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/.

This role is open to candidates anywhere in the United States. Stanford University has five Regional Pay Structures. The compensation for this position will be based on the location of the successful candidate.

The expected pay range for this position is $80,000 to $93,000 per annum.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

Why Stanford is for You

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

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.

Stanford is an equal employment opportunity and affirmative action employer. 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.

As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit: https://cardinalatwork.stanford.edu/working-stanford/covid-19-workplace-guide/covid-19-interim-policies/covid-19-vaccination-policy

Additional Information

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• Schedule: Full-time
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• Job Code: 4923
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• Employee Status: Regular
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• Grade: H
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• Requisition ID: 98053
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