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.
This position is per diem, non-exempt and health insurance eligible. The pay range for this position is $32.40 - $48.60/hour. Pay is determined based on relevant experience and department equity.
- 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
Note: This is not an all-inclusive list of this job's responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned.
Required
-
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
-
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
