Clin Trials Pre-Awd Spc II

Job Description

Manages pre-award activities for an assigned portfolio of clinical trials within a Research Administration Services (RAS) unit using knowledge of grant, contract, and clinical trial management rules and regulations, technical expertise, and analytical skills. Pre-award activities include, but are not limited to, assisting departmental faculty/PI and clinical trial coordinators in the development, preparation, and submission of clinical trial proposals. Manages the day-to-day operations and objectives in support of the assigned portfolio. Contributes information and ideas related to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff/program and self. Interacts regularly with and provides high quality customer service to faculty members, clinical trial coordinators, and nurse managers conducting sponsored research/clinical trials. Will also interact with central offices assisting with clinical trial management, including the Office of Clinical Research (OCR) and Office of Sponsored Programs (OSP). Ensures all applications meet agency, company, and university guidelines and published time tables and deadlines, including management of the Just-In-Time process (as necessary). Ensures proposals are entered and routed in a timely manner for further review. For multi-site clinical trials, confers with PI and Pre-award support staff at collaborating institutions to secure necessary sub-award documents. Assists the PI and/or coordinator(s) in the development of budgets and budget justification which includes proofing the budget for inconsistencies and ensuring accuracy. Reviews budgets for consistency with sponsor, monitors compliance with agency and University regulations regarding submission; verifies all financial information to include application of the appropriate overhead rate for the project. Advises the PI and/or coordinator(s) on administrative requirements in preparing proposal submissions and/or coordinator(s) on budget adjustments and revisions necessary to meet the sponsor requirements. Coordinates and reviews certain proposal elements (biosketches and facilities & resources) for consistency, accuracy, and completeness. Reviews proposals for consistency with sponsor guidelines on budget, format, font size, page limits excluding narrative content (obtain and review sponsor guidelines). Monitors and facilitates proposal process through the routing process in compliance with University procedures and institutional signatures. Obtains signatures as needed. Monitors proposal status and advises PI and/or coordinator(s) on requirements and deadlines associated with research protection protocols. Analyzes data and formulates conclusions. Prepares high-quality written documents. Works effectively with other offices (central, school, departments, divisions) on research proposal. Performs related responsibilities as required.

Minimum Qualifications

Bachelor's degree and three years of work-related grants, contracts, and clinical trials experience OR an equivalent combination of education, training and experience. Knowledge of federal rules and regulations and sponsor requirements relating to research grants and contracts, specifically clinical trials. Proficiency with MS Office Suite software.