Emory University Senior Clinical Trials Regulatory Specialist in atlanta, Georgia

Description

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.

MINIMUM QUALIFICATIONS: 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.

PREFERRED QUALIFICATIONS: A keen interest or experience in research. Prior history of working within a team to meet objectives. Willingness to be flexible and to obtain all necessary credentials. Expected to follow protocol specific Lab SOP’s. Experience working with assays is preferential by not essential.

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Job Number 22523

Job Type Regular Part-Time

Division School Of Medicine

Department SOM: Peds: Infectious Disease

This position may involve the following Health and Safety issues: Not Applicable

Job Category Laboratory

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled