Clinical Research Coordinator II

Company Overview

Shriners Children’s is an organization that respects, supports, and values each other. 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.

The Clinical Research Coordinator II is a specialized, independent research professional who ensures oversight and compliance of both system-wide and local SC (Shriners Children’s) clinical research activities. Reporting to the Clinical Research Program Manager (or local Hospital Administrator/Clinic Director) and Research Programs Office at SC International Headquarters, the CRC II provides support in accordance with SC’s policies and procedures, SC’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 SC’s vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC II 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.

• Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the complex clinical research process, from protocol development to implementation.
• Supports the investigators’ development of SC investigator-initiated research protocols. Performs critical analysis of proposed research projects in order to determine appropriateness and feasibility at the local site, including the evaluation of resources required, budgeting, and regulatory requirements.
• Supports the implementation of approved research protocols. Ensures studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, SC policies and standards.
• Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information, patient recruitment activity, and financial management. Actively collaborates with applicable headquarters departments, including Research Programs, Legal, and Compliance related to protocol reviews, IRB submissions, sponsored contracts, material transfers, data use agreements, and HIPAA compliance for projects conducted within SHC. Provides direction and education to clinical research staff on protocol-related activities.
• Works closely with investigators, research leadership, study sponsor and regulatory agencies to conduct and report the results of clinical research.
• 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. Effectively provides information about the use of investigational products to patients.
• Understands and adheres to safety monitoring and reporting requirements of regulatory agencies that oversee use of an investigational product in research.

• Coordinates the collection, statistical analysis and dissemination of data results throughout a clinical study.
• Evaluates protocols under consideration for feasibility, including the process for data collection, entry, storage and reporting. Assists in the development of procedures to standardize data collection and management, including the safeguarding of data, for each protocol. Responsible for timely data collection. Ensures accurate entry of research and outcome data into secure research databases.
• Verifies data accuracy through internal quality control measures to confirm reported study data is accurate,…