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 plus 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-CTP 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.
This position is a 1-year position with an opportunity to extend to 2 years.
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.
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.
- Other duties may also be assigned
All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.
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. The pay range for this position working in the California Bay area is $84,856.00 to $97,021.00 annually.
DESIRED QUALIFICATIONS:
*Bachelor's degree in science, medicine or related field.
*Prior experience coordinating drug and device clinical trials.
*Experience with charting in medical records and scheduling clinical appointments
*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.
Experience with project management software and MS Excel, Smartsheet, RedCap or other database programs.
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.
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.
Why work at Stanford?Stanford University has changed the world, over and over again.We are one of Silicon Valley's largest employers - and also one of the most unique. Our mission is to educate future leaders and promote interdisciplinary, world-class research and teaching. This passion makes Stanford an intensely creative, rewarding, and challenging place to work. At the same time, our traditions of respect and collaboration sustain a humane, supportive environment in which to pursue your life and your career.At Stanford you'll work with bright, diverse, dedicated people. You'll find encouragement to learn and grow. You'll enjoy excellent benefits and an outstanding environment. How will it change you?
