Clinical Research Spec II

Assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned. Assists in day-to-day operations and the implementation of clinical research protocols. Assists in carrying out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. Assists in assuring the overall integrity of studies. Assists in monitoring and adhering to standards, regulatory guidelines, and approved operational procedures. Works closely with study team members and other study sites to ensure study participant safety and adherence to approved protocols. Helps with study-related administrative tasks, facilitates the across-the-board flow of information, and assists in coordinating study activities and personnel.

Responsibilities

Assists in the planning, coordinating, implementing, monitoring, and evaluating specific clinical research studies as assigned; Assists in day-to-day operations and the implementation of clinical research protocols; Coordinates enrollment of participants; Manages and coordinates studies that are of a moderate size and complexity; Maintains study continuity and coordinates study participants and research procedures; Performs data collection and entry activities according to protocol requirements; Maintains logs, including OnCore entry and research tabs in the EMR; Complies with Good Clinical Practice and the Code of Federal Regulations; Other duties as assigned

Requirements

Bachelor's degree and 1 year of relevant experience required; equivalent combination of education and experience; Ability to understand, follow and coordinate standard research protocols and procedures; Fully adheres to applicable safety and/or infection control standards; Understands and follows data integrity standards and processes

Nice to have

Strong interpersonal, communication, and organizational skills; Highly collaborative, ability to work well in teams; Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet