Supports clinical research team (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations. Manages identified issues and provides feedback to leadership regarding resolution. Disseminates information and participates in training. Provides direction and feedback to research team to ensure awareness of business practices and quality standards. Documents any exceptions to compliance standards.
Manages new submissions and continuing review activities. Reviews initial submissions to determine review category and action to be taken. Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities. Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical). Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports. Attends research team meetings to report on regulatory issues. Responsible for administrative duties corresponding to budgets and contracts. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree and two years of experience in a research environment, or an equivalent combination of experience, education and training. Knowledge of clinical research practices. Must complete all required training courses within one month of hiring date.
--80385BR, 76520BR and 77814BR