Clinical Research Operations Manager II

2 weeks ago

Stanford CA, United States Stanford University Full time

About the Organization: The Stanford Center for Clinical Research (SCCR) is an expanding academic research institution within the Stanford Department of Medicine. Our goal is to facilitate and advance high-impact, innovative clinical research aimed at enhancing human health.

Position Overview: SCCR is in search of a Clinical Research Operations Manager II to oversee and manage multi-site clinical trials across various therapeutic domains, including cardiovascular medicine.

Key Responsibilities:

  • Manage virtual and multi-site operations, ensuring effective study initiation, regulatory submissions, and comprehensive training for each study site in preparation for activation.
  • Assist in the comprehensive management of studies from initiation to closure, ensuring compliance with regulatory standards.
  • Lead efforts in the collection of participant safety data and draft/review study Operations Manuals and Documents.
  • Develop effective strategies for participant recruitment and retention in long-term clinical trials.
  • Oversee data management for research projects, including the development and management of systems for data organization, collection, reporting, and monitoring.
  • Formally supervise, train, and mentor new staff or students, including involvement in hiring and performance evaluations.
  • Audit operations to ensure compliance with applicable regulations and recommend improvements to policies and processes.
  • Collaborate with staff and principal investigators to develop study budgets, distinguishing between standard care and study procedures.
  • Track patient and study-specific milestones, ensuring timely invoicing of sponsors according to study contracts.
  • Ensure ongoing regulatory compliance through regular inspections of study documents.
  • Work with principal investigators to submit Investigational New Drug applications to the FDA when applicable.

Qualifications:

  • Bachelor's degree in Clinical Research, Public Health, Business, or a related field.
  • A minimum of 2 years of experience in project management and clinical research.
  • Excellent verbal and written communication skills.
  • Proven ability to draft manuals and procedural documents.
  • Familiarity with Clinical Research Study Startup processes, including IRB submissions and site feasibility analyses.
  • Experience in supervising, training, and mentoring new staff or students.
  • Strong leadership skills for recommending and implementing policy improvements and best practices.
  • Proficiency in Microsoft Office and database applications.
  • Knowledge of medical terminology and experience with research protocols and regulatory bodies, including HIPAA and FDA regulations.
  • Certification from the Society of Clinical Research Associates or Association of Clinical Research Professionals is preferred.

Work Environment: This role may require occasional physical activities such as sitting, reaching, and performing desk-based tasks. Candidates should be prepared to comply with all applicable University policies and procedures.

Benefits: Stanford University offers a comprehensive range of benefits, including retirement plans, generous time-off, and health care benefits, as well as opportunities for career development and educational reimbursement.

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