Clinical Research Operations Specialist II

2 weeks ago

Stanford CA, United States Stanford University Full time

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

Position Overview: SCCR is on the lookout for a Clinical Research Operations Specialist II to oversee and execute a significant multi-site clinical trial focused on cardiovascular medicine.

Key Responsibilities:

  • Provide real-time assistance to study sites for urgent inquiries.
  • Lead initiatives for the collection of participant safety information.
  • Review and assess study Operations Manuals and related documents.
  • Offer non-urgent support to study sites affecting enrollment and safety.

At SCCR, we value team members who are dedicated, adaptable, and eager to achieve results. We prioritize equipping our staff with the necessary tools to perform their roles effectively, fostering skill development and career growth.

Work-Life Balance: We promote a healthy equilibrium between professional responsibilities and personal life, providing resources to support this balance.

Additional Duties:

  • Formulate effective strategies for participant recruitment and retention in long-term clinical trials.
  • Oversee data management for research initiatives, developing systems for data organization, collection, reporting, and monitoring.
  • Extract, analyze, and interpret data as required.
  • Establish project timelines, objectives, and accountability measures.
  • Supervise, train, and mentor new staff or students, including performance evaluations and project guidance.
  • Conduct audits of operations, including laboratory procedures, to ensure adherence to relevant regulations.
  • Collaborate with staff and principal investigators to create study budgets, distinguishing between standard care and study procedures.
  • Monitor patient and study-specific milestones, invoicing sponsors in accordance with study agreements.
  • Ensure compliance with regulatory standards, regularly reviewing study documentation.
  • Work with principal investigators to submit Investigational New Drug applications to the FDA when necessary.

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.
  • Exceptional verbal and written communication skills.
  • Proven ability to develop manuals and procedural documents.
  • Familiarity with Clinical Research Study Startup processes, including IRB submissions and site feasibility analyses.
  • Experience in supervising, training, and mentoring staff or students.
  • Strong leadership capabilities for recommending and implementing policy/process improvements.
  • Proficiency in Microsoft Office and database applications.
  • Knowledge of research protocols and regulatory bodies, including HIPAA and FDA regulations.
  • Understanding of medical terminology.

Physical Requirements: The role may involve occasional sitting, reaching, performing desk-based tasks, and lifting objects up to 40 pounds. There may be rare instances of kneeling, crawling, or climbing ladders.

Commitment to Diversity: Stanford University is committed to providing equal employment opportunities and will accommodate applicants and employees with disabilities as required.

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