Ensure oversight and compliance of system-wide and local SHC clinical research activities
Provide support in accordance with SHC's policies and procedures, SHC's hospital regulations, the Code of Federal Regulation and Good Clinical Practice guidelines
Recruit and consent SHC’s vulnerable pediatric subjects ethically
Collect and safeguard research data and specimens
Serve as primary liaison among research participants, local investigators, and study sponsors
Ensure proper study conduct, subject safety, and the quality of data and data safeguards
Maintain a contemporary knowledge of clinical research regulatory requirements
Coordinate system-wide and local project activities and collaborate with investigators, research leadership, study sponsors, and regulatory agencies
Contribute to protocol development through implementation and report study results
Perform other related duties and participate in special projects as assigned
Requirements
3 or more years Clinical research experience, e.g. experience with site management, study management, IRBs, 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’s in Clinical Research, science or other health-care-related field
Preferred: Master's Clinical Research, science or other health-care related field
Experience in the coordination of intergroup or multi-site clinical studies
CCRP or CCRC certification
Working knowledge of the complex clinical research process, from protocol development to implementation
Knowledge of the Code of Federal Regulation and Good Clinical Practice guidelines
Ability to ethically recruit and consent pediatric subjects and appropriately collect and safeguard data
Experience acting as liaison among research participants, investigators, and sponsors