Stanford University received funding from the Patient-Centered Outcomes Research Institute to investigate patient-centered opioid tapering in 865 patients with chronic pain in 5 primary care and pain clinics in 4 Western states (CA, CO, UT, AZ). We seek an experienced clinical trials manager for this 5-year project.
Within the context of voluntary opioid tapering, a team led by Beth Darnall, PhD will conduct a 3-arm comparative effectiveness trial involving: (1) pain-CBT, (2) the chronic pain self-management program, and (3) opioid taper only (no behavioral support). Study sites include the Veterans Affairs (Phoenix), Intermountain Health in Salt Lake City, Stanford Pain, Stanford Primary Care, and a private pain clinic in Frisco, Colorado. Each site will have a study coordinator to facilitate patient recruitment, enrollment, and conduct of the study within clinical care. We will use CHOIR (Collaborative Health Outcomes Information Registry) as our multi-site informatics platform https://choir.stanford.edu/ with all data being stored at Stanford.
The Core Manager will oversee the conduct of the multi-state study, and will supervise all study site research coordinators in the research protocol. The Core Manager will be a key member of the Informatics and Analytics Core, and will interface regularly with the Executive Research Team.
Excellent research management skills are required, including expertise in conducting randomized, controlled clinical trials. The Core Manager role involves close oversight of all aspects of CHOIR data management, data integrity, quality assurance across all aspects of treatments, including fidelity to opioid tapering and behavioral treatments (expertise in the specifics of the treatments is not required). The Core Manager will convene and lead meetings including up to 30 project stakeholders, and will be responsible for working with the PI, physician site directors and other project leads to meet project milestones. Excellent communication skills required, and a history of project/team management. Pragmatic, clinical experience is desired but not required. Expertise in managing single-site, large, federally or nationally-funded behavioral research clinical trial is essential; experience running multi-site behavioral research clinical trial is desired. The Core Manager office will be situated in Palo Alto, CA, at Stanford Systems and Neuroscience Pain Lab http://med.stanford.edu/pain/snapl.html
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 and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
Lead or chair committees or task forces to address and resolve significant issues.
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.
Assist with analysis of data and preparation of manuscripts and scientific presentations.
Other duties may also be assigned
Masters degree preferred.
Demonstrated experience in management and supervision.
Experience running multi-site behavioral research clinical trials.
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
Expertise managing single-site, large, federally or nationally-funded behavioral research clinical trial.
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.