Fiscal, Budgetary, & Grants Management – Provides financial administration and management for clinical research projects, including federal and non-federal sponsored grants and contracts. Reviews and analyzes sponsored program financial information, develops cost projections and provides financial tracking and fiscal controls. Prepares specialized reports, renewals, extension requests, and budget / effort modifications to grant agencies and participates in negotiations to substantiate budget requests and to secure terms and conditions sought by award PI and the university. Works closely with PI to formulate strategic financial approaches for his sponsored awards in dynamic coordination with industry partner funding sources. Possesses a high level of understanding and capabilities with UFIRST, PeopleSoft, IBM Cognos, eRA Commons, and other sponsor reporting platforms. Manages and closely monitors sponsored project expenditure activities to ensure compliance with sponsor terms, applicable statutes & regulations, and university policies. Prepares reports which summarize and forecast research business activities and financial performance. Ensures that charged and cost shared effort commitments by key personnel are fulfilled, that all salary distributions to sponsored projects accurately reflect performed effort, and that all grant-related effort is accurately reported prior to certification. Works closely with the DOM grants team, UF Division of Sponsored Programs, and UF Contracts and Grants to facilitate the effective execution of the sponsored research activities as directed by the PI. Manages the financial, budgetary, and operational components of all subawards and research contracts with collaborating institutions and businesses. Works with administrators at other institutions on subaward agreements, budgeted funding, invoice approvals, PI certifications, cost sharing, and other subaward management activities. Assists PI with approval of subrecipient invoices. Works with UF colleges & departments on award subproject setup and funding as well as payroll distribution, cost sharing and other award management activities. Understands and is highly knowledgeable of 2CFR§200 Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 48CFR§9905 Cost Accounting Standards for Educational Institutions, FDA, NIH, DOD, NSF, FLDOH & other sponsors’ grants policies, and UF Policies on Research. Provides clarity and guidance on key grants, regulatory, and operational policies that impact the research mission. Works closely with PI and collaborators to develop grant proposals including integrated budget, budget justification, and research scope of work documents. Understands the details of the funding opportunity and advises faculty on budgeting, expenditure, salary cap, F&A, and other financial guidelines that apply to the award. Provides administration and management of research program procurement and contracting activities. Negotiates contract terms and resolves problems with collaborating with study sites and suppliers. Formulates and executes business systems and policies for efficient purchasing activities through an integrated ordering platform.  Directs and supervises staff in support of this function and provides ongoing training to staff on purchase order activities, encumbrance management, payment vouchering, and supplier relations. Formulates and manages the processes for collection and retention of invoices and proof of delivery documents for clinical research expenditures in a searchable directory for sound record keeping and audit-readiness.

Clinical Research Operations – Manages multi-center clinical research activities led by a senior faculty member/PI, including support for PI sponsored Investigational New Drug (IND) and related external audits. Works closely with PI to plan and direct clinical research activities. Serves as the trial manager for IRB regulated clinical study activities. Develops and implements policies and procedures for the clinical research program. Assists PI in the interpretation and implementation of policies and procedures pertaining to clinical research operations and recommends changes to policies and procedures as necessary. Responsible for overseeing and maintaining clinical trial reports including subject enrollment logs, reportable events, cumulative adverse events tables, protocol deviation reports, etc. Responsible for managing clinical trial SOPs and other formal documents pertaining to clinical trial practices and procedures. Serves as the research program’s key point of contact with collaborating investigators, study coordinators, and business managers. Assists in preparation of scientific abstracts, poster presentations, manuscripts, and multi-media presentations. Assists with conference planning and travel logistics.

Regulatory Administration – Performs IRB related activities including execution of protocol revisions, continuing reviews, reportable events, and other IRB submissions. Attends IRB meetings on behalf of study team. Responsible for FDA reporting and submissions including IND annual reports, charging and meeting requests, etc. Manages and provides updates to active clinical studies in clinicaltrials.gov.

Study Coordination / Patient Care – Performs study coordinator duties in a backup capacity as needed, including obtaining informed consents, laboratory diagnostics orders and processing, exam scheduling and coordination. Assists investigating physicians and nurses with patient examinations; communicates with and provides support to patients/subjects and/or their caregiver. Performs auditing/ monitoring of clinical data generated by collaborating study sites. Oversees the preparation and distribution of research laboratory examination kits, as well as their submission by study sites to designated diagnostic and/or core laboratories.