Clinical Trials Activation Analyst 2

University of Miami; Don (WV); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Tuition remission

Job summary

The University of Miami seeks a full-time Clinical Trials Activation Analyst 2 to review financial provisions of sponsored research agreements and negotiate budgets in line with UM and regulatory requirements. This hybrid role is based at the Don Soffer Clinical Research Center in Miami, FL.

Responsibilities include preparing MCAs, advising on sponsor policies, and ensuring fiscally sound and compliant financial terms for clinical trials across departments.

Qualifications

• Bachelor’s degree required.
• Minimum 2 years of relevant experience.
• Strong written and verbal communication skills.

Responsibilities

• Review and negotiate financial provisions of clinical research agreements and proposals.
• Develop Medicare Coverage Analyses (MCAs) for studies to ensure compliance.
• Collaborate with IBC, IRB, Risk Management and external entities for compliant study management.
• Provide guidance to faculty and staff on sponsored research administration and sponsor policies.

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 2 to work hybrid at Don Soffer Clinical Research Center in Miami, Florida.

CORE JOB SUMMARY

The Clinical Trials Activation Analyst 2 (Medicare Billing Coding & Financial) works independently to review financial provisions of sponsored clinical research agreements and proposals and negotiate budgets and financial terms in adherence to sponsoring entity, federal, state and University of Miami requirements. Under general supervision, the Clinical Trials Activation Analyst 2 is responsible for providing institutional-level sponsored research administration services to a portfolio of academic departments and research units among the Miller School of Medicine, including communications with extramural entities, with the focus on securing fiscally sound and compliant financial provisions for clinical research and clinical trials.

CORE JOB FUNCTIONS

1. 1. Reviews, analyzes, negotiates and endorses financial provisions of various 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. 2. Determines applicability and develops Medicare Coverage Analyses (MCAs) for all applicable studies that are compliant, consistent with University policies and state and federal regulations to protect University resources and foster fiscally sound budgets and research billing compliance.
3. 3. 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) and other relevant offices to ensure that sponsored research projects are managed in a compliant, efficient and effective manner, consistent with UM policies and procedures and applicable extramural entities guidelines, laws and regulations.
4. 4. Provides advice to faculty and staff regarding sponsored research administration functions and interprets a broad range of sponsor policies, government regulations, terms and conditions.
5. 5. 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.
6. 6. 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.
7. 7. Keeps current on relevant professional information by attending professional development opportunities and trainings and proactively monitoring publications and updates from relevant agencies.
8. 8. Assists MSOM leadership with special projects as needed.
9. 9. 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 2 years of relevant experience required

Knowledge, Skills and Abilities:

• 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.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status:

Full time

Employee Type:

Staff