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Clinical Research Coordinator II

150 Shriners Hospitals for Children
locationSacramento, CA, USA
PublishedPublished: 6/14/2022
Healthcare
Full Time

Job Description

Job Description

Company Overview

Shriners Children’s is an organization that respects, supports, and values each other. Named as the 2025 best mid-sized employer by Forbes, we are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience define us as leaders in pediatric specialty care for our children and their families.

With 20+ hospitals, outpatient clinics, ambulatory care centers and outreach locations across the globe, we provide excellent care to children up to age 18 regardless of their family’s ability to pay or insurance status. Please click here to learn more about our locations.

Job Description

The Clinical Research Coordinator, Level 2 (CRC2) is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities. Reporting to the Clinical Research Program Manager (or local Hospital Administrator/Clinic Director) and Research Programs Office at SHC International Headquarters, the CRC provides support in accordance with SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The CRC works closely with the Chief of Staff, SHC scientific and medical staff and other research personnel to ethically recruit and consent SHC’s vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC is the site’s primary liaison among research participants, the local investigator(s) and study sponsor(s). This position’s main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards.

Key Responsibilities:

  • Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation

  • Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management

  • Responsible for oversight and documentation of the delivery, storage, and disposition of investigational products at the site, in accordance with federal and state regulations and sponsor requirements

  • Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study

  • Contributes in compiling, critically analyzing and preparing study results to share with research team

  • Demonstrates knowledge of ethical standards set forth by the Belmont Report, the Nuremberg Code and the International Conference of Harmonization GCP standards

  • Safeguards all participants involved in a research study supported and approved by Shriners Hospitals for Children. Maintains patient safety and privacy throughout the study

Required Qualifications:

  • 3 or more years of clinical research experience, e.g. experience with site management, study management, IRB's, and federal regulations regarding clinical research compliance.

  • Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research.

Preferred Qualifications:

  • Bachelor or Master's, science or other healthcare related field

  • CCRP or CCRC certification

  • Experience in the coordination of intergroup or multi-site clinical studies

  • Knowledge of how drugs, devices and biologicals are developed and regulated

  • Previous experience with study management, safety management and handling of investigational product

  • Experience with study and site management, including the financial and personnel aspects

The pay range for this position is $31.90 - $61.79. Compensation is determined based on years of relevant experience and departmental equity.