Supervisor, Clinical Research Operations Pre-Award

Overview 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. The role requires a deep understanding of systems and workflows and the ability to perform all aspects of the team’s work as needed. A key focus is monitoring and meeting Key Performance Indicators (KPIs), including Service Level Agreements (SLAs) for activation or amendments. Responsibilities Effectively leads the day‑to‑day functions of the clinical research pre‑award. Assigns and oversees the daily activities of the Clinical Research Pre‑Award team, ensuring timely and high‑quality 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. Monitors and manages all relevant reports and dashboards daily, ensuring that KPIs and SLAs are tracked and met consistently. Provides regular updates to leadership regarding team performance, project progress, and any identified issues or opportunities for improvement based on data analysis. Partners with external vendors to foster open communication and establish streamlined processes that ensure high productivity and quality outcomes in pre‑award clinical research deliverables. Delivers guidance, training, education, and coaching to vendor‑related workflows and responsibilities, promoting a culture of efficiency, accuracy, and excellence in all work outputs. Monitors and enforces vendor performance standards, ensuring accountability for assigned tasks and adherence to agreed‑upon timelines, quality metrics, and contractual obligations. Assesses 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 process. Assumes additional duties as assigned by the manager to support the operational needs and strategic objectives of the clinical research pre‑award team and/or Clinical Trial Business Office Department. Provides interim coverage and support for team members during staffing vacancies, ensuring continuity of pre‑award processes and deliverables. Completes specialized projects and stretch assignments delegated by the manager to enhance skills, contribute to team goals, and drive process improvements within the Clinical Trial Business Office Department. Credentials and Experience Bachelor’s Degree – field of study: Business Administration, Nursing, Finance, Healthcare, or related field. Five (5) years’ experience inclusive of: Three (3) years of direct clinical research experience in a pre‑award activity. Two (2) years’ experience in research compliance, finance, billing, coding, contract compliance, or revenue recognition/integrity leading less experienced team members as a mentor, senior or project lead. Skills / Specialized Training Clinical Research Expertise – Strong knowledge of various funded clinical trials, including the financial management aspects, budget development, payment term negotiations, and regulatory compliance. Supervisory & Leadership Skills – Proven experience in managing/leading a team, including overseeing daily operations, workload distribution, staff training, and performance management. Ability to motivate and guide staff toward achieving departmental goals. Budget & Financial Management – Expertise in ensuring budget accuracy for clinical trials, including trial activation, amendment processing, and negotiation of payment terms. Strong understanding of financial tracking and reporting in a clinical trial setting. Quality & Compliance Knowledge – In‑depth understanding of quality/compliance and institutional standards governing clinical trials, with the ability to ensure all processes align with these standards. Process Improvement & Efficiency – Demonstrated ability to drive process improvements, streamline workflows, and enhance team efficiency while maintaining high‑quality standards. System & Workflow Proficiency – Deep understanding of clinical trial management systems (such as OnCore) and workflows. Ability to perform all aspects of the team’s work as necessary, including calendar entry and document concordance. Key Performance Indicator (KPI) Monitoring – Experience in monitoring, tracking, and achieving KPIs and Service Level Agreements (SLAs) related to trial activation, amendments, and other key milestones. Strong Communication Skills – Excellent verbal and written communication skills, with the ability to negotiate and collaborate effectively with internal and external stakeholders, including clinical research teams, sponsors, and vendors. Attention to Detail – Exceptional attention to detail in managing clinical trial documentation, including Clinical Trial Agreements, Informed Consent Forms, and Coverage Determinations. Problem‑Solving & Decision‑Making – Strong analytical skills to identify potential issues or obstacles, with the ability to propose and implement effective solutions in a timely manner. Adaptability & Flexibility – Ability to adapt to changes in clinical trial processes, compliance requirements, and organizational priorities while maintaining a high level of performance and team morale. Time Management & Organizational Skills – Ability to manage multiple priorities and deadlines effectively, ensuring timely processing of trial activations and amendments. Preferred Experience Three (3) years’ experience in a leadership capacity. #J-18808-Ljbffr