The Stem Cell and Gene Therapy Clinical Trial Program (SCGT-CTP) in the Department of Pediatrics, Division of Stem Cell Transplantation and Regenerative Medicine, is seeking a Clinical Research Coordinator 2 to conduct clinical research and serve as the operations lead on complex studies and projects/assignments. S/he will manage significant/key aspects of a multi-faceted large study or all aspects of one or more small research studies. S/he will coordinate between Stanford Faculty, Hospital and Clinic staff, external laboratories/facilities and outside companies or medical centers. Successful candidates will be skilled communicators with the ability to adapt to a fast-paced work environment. The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials with drugs, devices and cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.
The mission of the SCGT-CTP is to translate basic discoveries into innovative cell and gene therapeutics to treat children with debilitating diseases for which there are no cures at present. The identification of curative therapies for such children will offer them new hope for health, improvement in their quality of life, and a reduction in medical costs compared to their present palliative therapies.
- 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.
* - Other duties may also be assigned
- Bachelor’s degree in science, medicine or related field.
- Prior experience coordinating drug and device clinical trials.
- Experience with oncology or hematology studies.
- Clinical research, scientific or medical experience strongly preferred.
- Excellent communication skills, decision-making and problem solving skills.
- A proven capacity to set priorities for teams, coordinate multiple assignments, work in a fast paced, multi-tasked environment, and exercise sound judgment in setting priorities.
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 with 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 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.
- Travel to/from patient care units.
*- 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.
- 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 disease and infections.
- Work may take place in various hospital units, clinic environments, and office environments.
- May require extended or unusual work hours based on research requirements and business needs.
- Some weekend and evening hours may be required as needed.
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