Clin Trials Pre-Awd Spc III

Job Description

Manages pre-award activities for a complex 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. Mentors and develops junior staff. 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. Works with other pre-award specialists to solve problems, answer questions, and give guidance on pre-award clinical trial activities and other clinical trial management topics on a daily basis. May support the day-to-day activities of a team of Pre and Post-Award Specialists and monitor workload distribution. Negotiates budgets with sponsors as needed. Analyzes data and formulates conclusions. Creates high-quality written documents. Manages a large volume of complex awards. Works with Post-Award Clinical Trial Specialists to coordinate inter-team meetings to facilitate collaboration between the pre-award and post-award teams, as necessary and appropriate. 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. Interacts with central offices assisting with clinical trial management, including the Office of Clinical Research (OCR) and Office of Sponsored Programs (OSP). Performs pre-award clinical trial activities for one or more units (school, department, or division) within a RAS Unit including, but not limited to, assisting departmental faculty/PI and clinical trials coordinators in the development, preparation, and submission of clinical trial proposals. 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. Confers with PI and Pre-award support staff at collaborating institutions to secure necessary sub-award documents for multi-site clinical trials. Assists the PI and/or coordinator in the development of budgets and budget justification. Reviews budgets for consistency with sponsor and 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 on budget adjustments and revisions necessary to meet the sponsor requirements. Coordinates and reviews certain proposal elements (biosketches, facilities and resources) for consistency, accuracy, and completeness. Reviews proposals for consistency with sponsor guidelines on budget, format, font size, page limits excluding narrative content (obtains and reviews sponsor guidelines). Monitors and facilitates proposal process through the routing process in compliance with University procedures and institutional signatures. Monitors proposal status and advises PI and/or coordinator on requirements and deadlines associated with research protection protocols. Works effectively with other offices (central, school, departments, divisions) on research proposal. Performs related responsibilities as required.

Minimum Qualifications

Bachelor's degree and five years of effective work-related grants, contracts, and clinical trials management 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.