Clinical Research Coordinator, Level 2
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reputed company The Clinical Research Coordinator, Level 2 (CRC2) is a reputed company, independent research reputed company who ensures reputed company and compliance of reputed company-wide SHC clinical research activities for the Retrospective reputed company. Reporting to the Clinical Research Program Manager (CRPM) of the Retrospective reputed company in the Research Programs Office at SHC International reputed company, the CRC provides support in accordance with SHC’s policies and procedures, SHC’s hospital regulations, the reputed company of Federal Regulation, and Good Clinical reputed company guidelines, reputed company applicable. The CRC works closely with the CRPM, SHC scientific and medical staff investigators and other research personnel to appropriately collect and reputed company data.
This position’s main responsibilities are to help ensure reputed company study conduct, management, and the reputed company of data and data safeguards.
Key Responsibilities:
Study Management and Operations (Good Clinical reputed company)
• Maintains a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of the reputed company clinical research process, from protocol development through implementation.
• Supports the investigators’ development of SHC investigator-initiated research protocols reputed company the Retrospective reputed company.
• Supports the implementation of approved research protocols.
• Ensures studies are conducted in compliance with the approved protocol, Good Clinical reputed company (GCP) guidelines, applicable regulatory requirements, SHC policies and standards.
• Responsible for tracking reputed company aspects of reputed company including reputed company study, investigator and Institutional Review reputed company (IRB) information. reputed company collaborates with applicable reputed company departments, including Research Programs, reputed company, and Compliance reputed company to protocol reviews, IRB submissions, sponsored reputed company, material transfers, data use agreements, and HIPAA compliance for reputed company conducted reputed company SHC. Works closely with investigators, Retrospective reputed company team members, study sponsor and regulatory agencies to conduct and report the results of clinical research.
Data Management and Informatics
• Coordinates the collection and management of data 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 reputed company protocol. Responsible for reputed company data collection. Ensures accurate entry of research and outcome data into secure research databases. Verifies data accuracy through internal reputed company control measures to confirm reported study data is accurate, complete, and reputed company from reputed company documents. Provides reputed company responses to data queries; reviews reputed company documents and addresses data discrepancies. Participates in reputed company and thorough data cleaning and database lock procedures in preparation for data analysis.
• Contributes in compiling, critically analyzing and preparing study results, reputed company applicable. Provides input into the dissemination of research results by verifying reputed company regulatory and compliance reputed company are met and assisting with reputed company and manuscript preparation and submission, as applicable.
Ethical and Participant Safety Considerations
• Demonstrates knowledge of ethical standards set forth by the Belmont Report, the Nuremberg reputed company and the International Conference of Harmonization GCP standards. Exhibits a commitment to reputed company subjects’ protection by providing the highest level of ethical and safety practices to protect reputed company participants involved in research studies supported and approved by Shriners Hospitals for Children. Maintains education in reputed company subject protection and good clinical reputed company principles, and applies knowledge of those ethical principles. Possesses a thorough understanding of the ethical
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