Clinical Trials Activation Analyst 3

University of Miami; Miami (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

University of Miami is seeking a Clinical Trials Activation Analyst 3 to join the Department of Clinical Trials Budgeting & Activation. The role is full-time with a hybrid schedule at the Don Soffer Clinical Research Center in Miami, Florida.

The analyst reviews complex clinical research budgets, negotiates financial terms, and ensures compliance with University policies, state and federal regulations, and sponsor guidelines.

Qualifications

• Bachelor's degree required.
• Minimum 4 years of relevant experience.
• Strong communication and teamwork skills.

Responsibilities

• Review financial provisions of complex clinical research agreements and proposals to ensure compliant budgeting.
• Negotiate budgets and financial terms with sponsors and internal stakeholders.
• Provide guidance to faculty and staff on sponsored research administration functions.
• Train and mentor department staff to develop talent and improve performance.
• Collaborate with Principal Investigators, Compliance Office, IRB, Risk Management and external sponsors to ensure compliant project management.
• Develop and share work processes, templates, and tools to improve budgeting and negotiations.

Skills

Learning Agility

Teamwork

Technical Proficiency

Communication

Education

Bachelor's degree

Job description

The Department of Clinical Trials Budgeting & Activation is seeking a full-time Clinical Trials Activation Analyst 3 to work hybrid at Don Soffer Clinical Research Center in Miami, Florida.

Core Job Summary

The Clinical Trials Activation Analyst 3 works independently to review financial provisions of complex sponsored clinical research agreements and proposals and negotiate budgets and financial terms in adherence to sponsoring agency, federal, state and University of Miami requirements. Under minimal supervision, the Clinical Trials Activation Analyst 3 is responsible for providing enhanced inter-departmental and institutional-level sponsored research administration services to various academic departments and research units among the Miller School of Medicine, including extensive communications with extramural entities, with the focus on securing fiscally sound and compliant financial provisions for complex clinical research and clinical trials. Moreover, the Clinical Trials Activation Analyst 3 participates in development of efficient work processes, support documents, templates and other tools to facilitate research budget development and negotiations.

Core Job Functions

1. Reviews, analyzes, negotiates and endorses financial provisions of complex clinical research agreements, proposals and awards to ensure use of the correct and compliant processes, and meeting funding requirements, focusing on University policies, Uniform Guidance and applicable federal and state rules and regulations.
2. Trains, and mentors department staff to develop talent and enhance performance.
3. Determines applicability and develops Medicare Coverage Analyses (MCAs) for all applicable studies that are complaint, consistent with University policies and state and federal regulations, to protect University resources and foster fiscally sound budgets and research billing compliance.
4. Collaborates with various University and external research entities, such as Principal Investigators and study teams, Compliance Office, IRB (Human Subject Research Office), Risk Management, Jackson Health System Clinical trials office (JHS CTO) sponsors and other relevant offices to ensure that sponsored research projects are managed in an efficient and effective manner consistent with UM policies and procedures, and applicable extramural entities guidelines, laws and regulations.
5. Provide advice to faculty and staff regarding sponsored research administration functions, interpreting a broad range of sponsor policies, government regulations, terms and conditions.
6. Maintains operations consistency and transparency and provides data on a work progress to appropriate Miller School of Medicine (MSOM) leadership and academic departments' research administration on an ongoing basis.
7. Collaborates with others at MSOM to ensure consistent, smooth and efficient processes for various pre and post-award activities related to research projects carried out by the University.
8. Provide mentorship to Clinical Trials Activation Analysts and assist with on-the-job training and onboarding of new hires.
9. Keep current on relevant professional information by attending professional development opportunities and trainings, proactively monitoring publications and updates from relevant agencies.
10. Assist MSOM leadership with development of reports and training materials and monitoring of work efficiency and productivity, suggesting new and efficient ways for carrying out assigned duties and other tasks as needed.
11. Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

Core Qualifications

Education: Bachelor's degree in relevant field required

Experience: Minimum 4 years of relevant experience required

• Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
• Teamwork: Ability to work collaboratively with others and contribute to a team environment.
• Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
• Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

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