Market Manager Clinical Research Operations

2 weeks ago


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

CommonSpirit Health, a leading healthcare organization, is seeking a highly skilled Market Manager Clinical Research Operations to join its team. With a strong commitment to advancing medical knowledge and improving patient care, our Research Institute offers comprehensive clinical research services and support for various research activities.

The ideal candidate will have a minimum of five years of experience in clinical trial management, with a proven track record of success in managing and supervising research staff. They will be responsible for providing local leadership and day-to-day supervision for all clinical trials, research activities, and site-based clinical research staff within their assigned regional research sites.

The successful candidate will be accountable for all site research activities, including adherence to Good Clinical Practice (GCP) guidelines, site timelines, quality control, and assurance of research study data collection. They will also be responsible for monitoring site staff productivity, clinical trial enrollment, and assignment of personnel resources to all research, including new research activities.

We offer a competitive benefits package, including medical, dental, and vision insurance, as well as a 401(k) match and paid time off. Our team is committed to building healthy communities, advocating for those who are poor and vulnerable, and innovating how and where healing can happen.

Responsibilities

The Market Manager Clinical Research Operations will be responsible for:

  • Serving as a central point of contact for and liaison to the research community to provide guidance related to the initiation and ongoing conduct of all research activity subject to CSHRI oversight.
  • Generating local support for research activities, including maintaining visibility with local leaders, physicians, and other clinicians, and patients regarding research opportunities and portfolio.
  • Accountable for all site research activities, including adherence to GCP guidelines, site timelines, quality control, and assurance of research study data collection.
  • Monitoring site staff productivity, clinical trial enrollment, and assignment of personnel resources to all research, including new research activities.
  • Working with the study team and CSHRI Leadership to determine best practices for research operations and study budget accuracy.
  • Accountable to ensure timely data entry and tracking for both study and site information via the Clinical Trial Management System (CTMS) and other research tracking technology.
  • Managing site staff resource allocation within budgeted targets.
  • Promoting a culture of individual accountability for quality assurance and improvement within the CRDM function and site research staff.
  • Functioning as a content expert in developing appropriate training/educational materials along with the CSHRI Research Integrity function for all site teams.
  • Developing, implementing, and evaluating performance standards and measurements to support research coordinator and investigator compliance with protocol, GCP, FDA, and other research regulatory requirements.

The successful candidate will be a key member of our research operations team, working closely with essential research constituencies, including facility research leadership, CommonSpirit Health administrators, physicians/investigators, site research personnel, CommonSpirit Health Legal, CommonSpirit Health Corporate Responsibility, and CommonSpirit Health IRB, as well as between CSHRI and industry and government sponsors of research, and government agencies including the U.S. Food and Drug Administration (FDA).

Qualifications

The ideal candidate will have:

  • A minimum of five years of full-time experience in clinical trial management in a hospital and within an integrated health system.
  • A Bachelor's degree required, SOCRA or ACRP certification required or must meet eligibility criteria to become certified within one year of hire.
  • A minimum of three years' experience managing and supervising research staff.
  • Demonstrated knowledge of Medicare coverage analysis and research billing compliance required.
  • Demonstrated knowledge of Federal (GCP, ICH), State, and other research regulatory requirements required.
  • Previous experience with Clinical Trial Management Systems (CTMS).
  • A minimum of 2 years of experience in research contract and budget development and management preferred.


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