Clin Trials Regulatory Spc, Sr

     
Pay Range Minimum
Job Code:
SE23
Hourly:
$25.38
FLSA*:
Exempt
Monthly:
$4,400
Grade:
233
Annually:
$52,800

*This is an Exempt position. Employees in this position are paid a salary on a monthly basis and are not eligible to receive overtime pay.

JOB 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.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

EQUAL EMPLOYMENT OPPORTUNITY / AFFIRMATIVE ACTION EMPLOYER:

Emory University is dedicated to providing equal opportunities to all individuals regardless of race, color, religion, ethnic or national origin, gender, age, disability, sexual orientation, gender identity, gender expression, veteran's status, or any other factor that is a prohibited consideration under applicable law.

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