Clinical Research Coordinator II

Job Description

Job Description

Overview

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. Shriners NCAL is looking for a full time Clinical Research Coordinator II to join the team!

This position is full time, 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.

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

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.

Qualifications

Required

• 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

• 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