Note: The job is a remote job and is open to candidates in USA. Shriners Children’s is an organization that respects, supports, and values each other. The Clinical Research Coordinator II is responsible for overseeing and ensuring compliance of clinical research activities, recruiting and consenting pediatric subjects, and safeguarding data throughout the research process.
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
Skills
- 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
- 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
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