Associate Director – MCHRI Research Coordinator Services

at  Stanford University

Stanford University is seeking an Associate Director to lead the Stanford Maternal and Child Health Research Institute’s (MCHRI) Research Coordinator Services Program.

The mission of MCHRI is to mobilize Stanford discoveries and expertise to improve healthier lives for expectant mothers and children. MCHRI’s strategic goals are to:

• Focus Stanford’s intellectual talent on solving the greatest health challenges facing expectant mothers and children
• Increase the number of future academic leaders dedicated to these problems
• Accelerate innovative research to make transformational discoveries
• Enable the translation of our discoveries into action, and
• Promote maternal and pediatric health and well-being, nationally and globally

The Associate Director of Research Coordinator Services Program at MCHRI will oversee all operational conduct and personnel for maternal and child health clinical trials/studies including investigator-initiated trials and other sponsored trials as defined by the Code of Federal Regulations (CFR) and International Council of Harmonization (ICH). They will be under the direction of the Executive Director of MCHRI and Principal Investigators across the School of Medicine. The Associate Director will oversee all aspects of study conduct from start-up through close-out and be responsible for supporting Good Clinical Practice (GCP) to enroll and treat participants on clinical trials/studies with utmost safety and integrity. The Associate Director will lead a team of research managers and research coordinators in activities that include the following: study feasibility assessment; site activation; operationalizing protocols in clinical settings; participant enrollments; directing Standard Operating Procedures and study tools generation; ensuring correct processes for participant eligibility, treatment and follow-up; safety reporting; site monitoring preparation; ensuring data integrity; reporting study metrics to sponsors and senior leadership; study resource management; and training and development of operations personnel. They will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care in maternal and child health. The successful candidate will demonstrate professionalism, initiative, creativity and a commitment to impeccable research methods and compliance.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor’s degree plus five years of relevant experience, or combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Demonstrated experience leading and managing clinical trial staff.
• Demonstrated experience leading multi-site or large-scale clinical trials research.
• Ability to run a high-quality clinical research organization, organizing and motivating teams to follow good clinical practice and regulatory requirements, while providing excellent patient care and study conduct.
• Demonstrated ability to work and communicate effectively with others, collaborate and build relationships across all levels of an organization.
• Project management experience in a research environment.
• Strong knowledge of industry standards and/or regulatory requirements.
• Knowledgeable about insurance billing, and the Medicare Coverage Act.
• Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
• Excellent written, verbal, interpersonal, and presentation skills.

PHYSICAL REQUIREMENTS*:

• Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
• Occasionally stand, use a telephone or write by hand.
• Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
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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.

• Make decisions regarding clinical research projects, programs, and initiatives. Develop and implement research goals for a clinical trial for a department or institute providing services to multiple faculty.
• Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct.
• Select, develop, and evaluate personnel to ensure the efficient operation of the function including hiring, performance management, and related duties.
• Provide direction to PI’s, Clinical Research Managers on staffing needs, funding and resources in order to meet the needs of individual research efforts and overall research group.
• Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge.
• Provide direction for the clinical sites to establish protocol development. Review clinical practices, case report forms, and reports.
• Liaise with senior management ad cross functional areas and schools. Serve as a liaison to external organizations/agencies (FDA, NIH, Hospitals). Negotiate and establish external resource contracts.
• Manage and coordinate assigned multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of actives that meet objectives of assigned research protocol(s).
• Access protocols internally, evaluate documentation for feasibility, conduct, and compliance. Provide expertise to improve protocol quality and completeness.
• Administer the budget, assign resources accordingly and assist with grant budget proposals.
• 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. ~