Supervisor, Clinical Research Operations Pre-Award

Moffitt Cancer Center•Tampa, FL

16h

About The Position

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.

Requirements

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.
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 towards achieving departmental goals.
Budget & Financial Management: Expertise in ensuring budget accuracy for clinical trials, including trial activation, amendment processing, and the 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 Determination.
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.

Nice To Haves

3 years' experience in a leadership capacity.

Responsibilities

Effectively leads the Day-to-day functions of the clinical research pre award.
Assign and oversee 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.
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 process.
Assume 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.
Provide interim coverage and support for team members during staffing vacancies, ensuring continuity of preaward processes and deliverables.
Complete 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.