Emory Healthcare/Emory University Part-Time Senior Clinical Trials Regulatory Specialist, SC2i in Atlanta, Georgia
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The Surgical Critical Cares Initiative (SC2i) team seeks a highly experienced motivated Senior Clinical Trials Regulatory Specialist. Strong knowledge and experience in Regulatory Compliance and Quality Assurance preferred. Improving critical-care decisions can save lives and improve recovery. The Surgical Critical Cares Initiative (SC2i) processes data from participating studies at world-class civilian and military research hospitals to create clinical decision-support tools that focus clinicians on the best choices for each patient. SC2i is focused on developing, translating, and validating biology driven critical care. This model of providing individualized treatment based on the underlying biology has the potential to dramatically improve patient outcomes while reducing costs. Biology driven care enables clinicians to reliably deliver the right treatment at the right time to ensure the best potential outcome at lower cost.
Supports clinical research team (physician-investigators, clinical research staff, nurses, etc.) in research efforts by facilitating the protocol approval process and overseeing documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
Establishes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations and guidelines.
Reviews processes involving regulatory documentation to assure appropriate timelines are followed.
Researches and analyzes problems and takes a leadership role in resolving.
Identifies and manages issues and provides feedback to leadership regarding resolution.
Disseminates information and coordinates or conducts training.
Reviews documentation of exceptions to compliance standards to assure information is accurate and complete.
Participates in the development and implementation of standard operating procedures, development and revision of regulatory orientation plans, and orientation and mentorship of newly hired staff.
Actively participates in designated committees within the unit and Emory University.
Performs related responsibilities as required.
Bachelor's degree and three years of experience in a research environment, or an equivalent combination of experience, education and training.
Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
Must obtain all required training courses within one month of hiring date.
Must possess an applicable research certification.
NOTE: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University location as needed. Emory reserves the right to change this status with notice to employee.
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Job Number 53597
Job Type Regular Part-Time
Division School Of Medicine
Department SOM: Surgery: Transplant
This position may involve the following Health and Safety issues: Not Applicable
Job Category Laboratory
Location : Name Grady
Campus Location (For Posting) : Location US-GA-Atlanta
Emory Healthcare/Emory University
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