SUPERVISOR CLINICAL RESEARCH OPERATIONS PRE AWARD

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Summary

The Supervisor, Clinical Research Pre-Award oversees the financial management of industry-sponsored, federal, State of Florida, and privately funded clinical trials at Moffitt Cancer Center. This role leads the Pre-Award team, ensuring timely trial activation and amendment processing, budget and payment term negotiations, accurate OnCore calendar entry, and alignment of key documents such as the Clinical Trial Agreement, Informed Consent Form, and Coverage Determination.In addition to supervising daily operations, workload distribution, and staff training, the Supervisor is responsible for maintaining budget accuracy, ensuring compliance with regulatory and institutional standards, and driving process improvements. They are expected to have a deep understanding of systems and workflows and be able to perform all aspects of the team’s work as needed.A key focus of this role is monitoring and meeting Key Performance Indicators (KPIs), including Service Level Agreements (SLAs) for activation or amendments. The Supervisor ensures these metrics are met or exceeded while fostering an efficient, high-performing team.

 

The Clinical Research Supervisor overseeing calendar build and coverage analysis leads the operational and financial components of study start-up, ensuring accurate development of OnCore calendars and compliant coverage analyses that align with protocol requirements, contracts, and regulatory standards. This role supervises specialized teams (e.g., calendar builders and coverage analysts), manages workload distribution, and ensures timely study activation and amendment processing in accordance with established SLAs and KPIs Position Highlights: The Supervisor, Clinical Research Pre-Award oversees the financial management of industry sponsored, federal, State of Florida, and privately funded clinical trials at Moffitt Cancer Center. This role leads the Pre-Award team, ensuring timely trial activation and amendment processing, budget and payment term negotiations, accurate OnCore calendar entry, and alignment of key documents such as the Clinical Trial Agreement, Informed Consent Form, and Coverage Determination. In addition to supervising daily operations, workload distribution, and staff training, the Supervisor is responsible for maintaining budget accuracy, ensuring compliance with regulatory and institutional standards, and driving process improvements. They are expected to have a deep understanding of systems and workflows and be able to perform all aspects of the team’s work as needed. A key focus of this role is monitoring and meeting Key Performance Indicators (KPIs), including Service Level Agreements (SLAs) for activation or amendments. The Supervisor ensures these metrics are met or exceeded while fostering an efficient, high-performing team. Responsibilities: • Effectively leads the Day-today functions of the clinical research pre award. • Assign and oversee the daily activities of the Clinical Research Pre-Award team, ensuring timely and highquality completion of tasks including calendar builds, coverage determinations, billing queries, compliance audits, quality controls, budget negotiations, budget development, payment terms, and document concordance for trial activation, amendments, and maintenance requests. • Monitor and manage all relevant reports and dashboards on a daily basis, ensuring that (KPIs) and SLAs are tracked and met consistently. • Provide regular updates to leadership regarding team performance, project progress, and any identified issues or opportunities for improvement based on data analysis. • Partner with external vendors to foster open communication and establish streamlined processes that ensure high productivity and quality outcomes in preaward clinical research deliverables. • Deliver guidance, training, education, and coaching to vendor-related workflows and responsibilities, promoting a culture of efficiency, accuracy, and excellence in all work outputs. • Monitor and enforce vendor performance standards, ensuring accountability for assigned tasks and adherence to agreed-upon timelines, quality metrics, and contractual obligations • Assess vendor work volumes, workflows, and processes to identify opportunities for improvement, implementing strategies to enhance operational efficiency and align with organizational goals in the pre-award research