Clinical Research Operations Manager

5 days ago


San Luis Obispo, California, United States Unavailable Full time
Overview

At Unavailable, we are committed to advancing medical knowledge and improving patient care through comprehensive clinical research services. Our team is dedicated to providing start-to-finish research support, from initiation to completion, ensuring the highest quality and compliance with regulatory guidelines.

The CommonSpirit Health Research Institute, a beacon of medical advancement, offers a wide range of clinical research services, including multi-site clinical trials, data research, and partnerships with industry and academia. As a key member of our team, you will play a pivotal role in advancing medical knowledge and improving patient care.

As a Clinical Research Operations Manager, you will provide local leadership and day-to-day supervision for all clinical trials, research activities, and site-based clinical research staff within your assigned regional research sites. You will work closely with essential research constituencies, including Investigators, research staff, and other internal and external research-related parties, to ensure the efficient and compliant initiation, ongoing administrative management, and support of research.

Key Responsibilities:

  • Liaison and Guidance: Serve as a central point of contact for the research community and guide research initiation and conduct.
  • Local Support: Generate local support for research activities, including maintaining visibility with local leaders, physicians, and patients.
  • Site Operations Management: Ensure adherence to GCP guidelines, site timelines, quality control, data collection, drug/device management, and staff training.
  • Resource Management: Monitor staff productivity, clinical trial enrollment, and resource allocation within budget targets.
  • Data Management: Ensure timely data entry and tracking via CTMS and other research tracking technology.
  • Quality Assurance: Promote a culture of accountability for quality assurance and improvement within the research function.
  • Training and Development: Develop and implement training materials for site teams.
  • Standardization and Centralization: Support standardization of regional research operations and centralize core research support services.
  • Strategic Planning: Participate in CSHRI research operations oversight and strategic planning activities.

Qualifications:

Required Education and Experience:

Education: Bachelor's degree required.

Licenses & Certifications: SOCRA or ACRP certification required, or eligibility to become certified within one year of hire.

Experience & Knowledge:

  • Bachelor's degree in life sciences or a related field required. Master's degree preferred.
  • Minimum five (5) years of full-time experience in clinical trial management in a hospital, clinic, or physician office setting required. Experience managing clinical trials within an integrated health system preferred.
  • Minimum three (3) years' experience managing and supervising research staff (e.g., clinical coordinators and regulatory staff) or 5 years leadership experience in the discipline or Master's Degree.


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