5+ years of clinical research administration experience without a Bachelor's degree
3+ years of clinical research experience including site and study management
Familiarity with electronic health systems and research databases
Solid understanding of clinical research regulations and guidance
Ability to learn participant and sample collection for large-scale studies
Knowledge of informed consent processes and sponsor policies
Responsibilities
Maintain up-to-date knowledge of clinical research regulatory requirements
Track all project aspects including study, investigator, and IRB information
Coordinate data collection, statistical analysis, and dissemination of results
Compile and critically analyze study results for the research team
Ensure patient safety and privacy throughout the study
Collaborate with SHC leadership to uphold the research mission
Maintain scientific integrity and excellence
Benefits
Supportive work environment focused on ethical research practices
Opportunity to work with vulnerable pediatric populations
Engagement with a multidisciplinary team of scientific and medical staff
Access to ongoing professional development and training
Involvement in cutting-edge clinical research initiatives
Full Job Description
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, 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
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
Maintains patient safety and privacy throughout the study
Works effectively with SHC leadership to ensure the research mission is upheld
Maintains scientific integrity, intellectual honesty, and excellence
Required Qualifications:
Without a Bachelor's degree, 5 or more years of specific job-related experience in the administration of clinical research is 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
Knowledge of, or ability to learn, electronic health system and databases used in research environments
Working knowledge of regulation and guidance(s) related to clinical research
Knowledge of, or ability to learn, participant and sample collection for large scale initiatives
Working knowledge of the applicable regulations related to product or agent being studied, the specific protocol, the informed consent process, and the sponsors' policies and procedures
Preferred Qualifications:
Bachelor's or Master's Clinical Research, science or other health-care related field
CCRP or CCRC certification
Experience in the coordination of intergroup or multi-site clinical studies
The pay range for this position is $32.40 - $48.60/hour. Compensation is determined based on years of relevant experience and departmental equity.
