88118 Requisition #

Stanford University received funding from the National Institutes of Health to develop and validate objective biomarkers for chronic pain. This study aims to develop biomarkers to predict the disease trajectory for individuals with musculoskeletal high-impact chronic pain. These biomarker signatures will integrate central nervous system (CNS), multi-omic, sensory, functional, psychosocial, and demographic domains into detection algorithms. Biomarker signatures from the proposed research are intended to facilitate risk and treatment stratification for clinical trial design and to facilitate treatment decisions in clinical practice for patients with musculoskeletal chronic pain. This project will involve deeply characterizing approximately 400 patients and integrate multiple labs.

We seek an experienced clinical trials manager for this 5-year project.

The Core Manager will oversee the conduct of the multi-lab study, and will supervise all study research coordinators in the research protocol. The Core Manager will interface regularly with the Executive Research Team.

Excellent research management skills are required, including expertise in conducting observational or treatment based clinical trials. The Core Manager role involves close oversight of all aspects of data management, data integrity, and quality assurance across all aspects of the patient characterizations. The Core Manager will convene and lead meetings including up to 20 project stakeholders, and will be responsible for working with the PI, Co-Is 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 research clinical trials is essential; experience running multi-lab 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. During COVID-19, much of the work will be conducted remotely.

Duties Include:

  • 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

Desired Qualifications:

  • Master’s degree preferred.
  • Demonstrated experience in clinical research management and supervision.
  • Experience running multi-lab research clinical trial.

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 research clinical trials.

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.

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.

* - 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.

Working Conditions:

  • 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.

Work Standards

  • 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.

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