Department of Medicine, Division of Pulmonary & Critical Care Medicine is seeking a Clinical Research Manager (CRM) to provide leadership and oversight of clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.
The CRM will manage clinical research for the Sean N. Park center, off-campus site in Mountain View, Packard El Camino (PEC). The clinical research team consists of 10 to 14 full-time research coordinators. The CRM will direct, lead, oversee, support and guide the clinical research team in all food allergy research programs for the successful management of clinical trials and translational research (Phase I- IV). The CRM will be responsible for oversight and strategic direction and implementation across a number of projects to ensure regulatory compliance and provide oversight of clinical staff, data entry and research analyses. Will oversee hiring and performance management of all staff involved in clinical research at SNP and will work closely with Operations Manager to ensure full compliance and discretion for hiring of staff.
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
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.
Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
Write and oversee SOPs and train staff and clinicians
* - Other duties may also be assigned
Five years of clinical research experience in an academic health center, pharmaceutical, biotechnology, or CRO industry or equivalent.
Clinical Research Certificate
Ensures work is done on time in a high quality manner
Knowledge of clinical pharmacology and pathophysiology, and food allergy research.
Demonstrated excellence in complex project management and effectively managing multiple projects/priorities
Experience managing cross-functional teams or work groups as well as direct reports.
Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials.
Strong regulatory knowledge and ability to perform monitoring of CRFs, GCP and GMP. This position must know IRB regulations and how to perform IRB submissions. Working knowledge of FDA procedures as applicable, and ICH-GCP and relevant SOPs.
Disciplined work approach with the ability to function independently, take initiative and effectively problems solve issues.
Customer service oriented both internally and externally with strong organizational, interpersonal and communication skills.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Excellent interpersonal skills.
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.
Demonstrated managerial experience.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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.
* - 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 diseases and infections.
May require extended or unusual work hours based on research requirements and business needs.
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
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.
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.
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains d...edicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 9000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu.
Stanford University is an equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.