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Clinical Trial Risk Based Monitoring Jobs in Kansas

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements ... based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package ...

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements ... based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package ...

Prior onsite monitoring experience including experience with Risk-Based Monitoring is preferred ... Working knowledge of clinical financials including understanding of budgets, pass- through and ...

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Clinical Trial Risk Based Monitoring information

What is clinical trial risk based monitoring?

Clinical Trial Risk Based Monitoring (RBM) is a strategy used in clinical research to prioritize and focus monitoring activities on the most critical risks to patient safety and data integrity. Instead of monitoring every data point equally, RBM uses data analytics and risk assessment tools to identify which sites, processes, or data require more attention. This approach increases efficiency, reduces costs, and helps ensure that potential issues are detected and addressed promptly. RBM is supported by regulatory agencies and is increasingly adopted in both large and small clinical trials.

How does a clinical trial risk based monitoring professional typically collaborate with cross-functional teams during a study?

In a Clinical Trial Risk Based Monitoring role, you will regularly work with clinical research associates, data managers, statisticians, and regulatory teams to identify and address potential risks throughout a study. Collaboration often involves participating in meetings to review data trends, sharing insights about site performance, and helping to develop mitigation strategies. Effective communication is crucial, as you will be responsible for ensuring that all stakeholders are informed of key risks and recommended actions. This collaborative environment helps drive patient safety, data integrity, and overall trial success.

What are the key skills and qualifications needed to thrive in clinical trial risk based monitoring, and why are they important?

To thrive in Clinical Trial Risk Based Monitoring, you need expertise in clinical research, regulatory compliance, and data analysis, usually supported by a degree in life sciences or related fields. Familiarity with risk assessment tools, EDC (Electronic Data Capture) systems, and GCP (Good Clinical Practice) certification is typically required. Strong attention to detail, critical thinking, and effective communication help professionals proactively identify and address potential risks in trials. These skills are crucial for maintaining data integrity, ensuring patient safety, and optimizing the efficiency and quality of clinical studies.

What is the difference between Clinical Trial Risk Based Monitoring vs Clinical Trial Data Manager?

AspectClinical Trial Risk Based MonitoringClinical Trial Data Manager
Primary FocusMonitoring trial sites for risks and complianceManaging and ensuring accuracy of trial data
Required SkillsMonitoring protocols, regulatory knowledge, site managementData management, database systems, quality control
Work EnvironmentClinical sites, monitoring visits, remote oversightData centers, clinical trial databases, office setting
CertificationsGCP, monitoring certificationsCDMP, data management certifications

While both roles are integral to clinical trials, Risk Based Monitoring focuses on overseeing site performance and compliance to mitigate risks, whereas Data Managers concentrate on managing and validating trial data for accuracy and integrity.

What are popular job titles related to Clinical Trial Risk Based Monitoring jobs in Kansas?

For Clinical Trial Risk Based Monitoring jobs in Kansas, the most frequently searched job titles are:

What cities in Kansas are hiring for Clinical Trial Risk Based Monitoring jobs?

Cities in Kansas with the most Clinical Trial Risk Based Monitoring job openings:

Clinical Trial Budget Analyst

University of Kansas Medical Center

Kansas City, KS โ€ข On-site

$61 - $91/hr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 2 days ago

New


Job description

Department

SOM KC Cancer Center Clinical Trials

Finance Position Title

Clinical Trial Budget Analyst - Cancer Center

Job Family Group

Professional Staff

Job Description Summary

The Budget Analyst performs budget development and negotiation with Pharmacy companies, as well as assist in the development of corresponding coverage analyses, for assigned clinical trials managed through The University of Kansas Cancer Center (KUCC) Clinical Trials Office. The University of Kansas Cancer Center is the region's only National Cancer Institute-designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

Job Duties Outlined

Consult with principal investigators, project directors, regulatory leads and the clinical trial budget manager on budget development for new study submissions as well as budget updates resulting from protocol amendments or other changes in scope. Responsible for developing and updating coverage analysis and clinical trial budget; ensure stakeholder review and agreement of draft budgets. Review and update financial language in Informed Consents pertaining to patient related costs on clinical studies. Consult with other KUMC stakeholders involved with clinical research financial administration, including: KUMCRI, KU Hospital, and the University of Kansas Cancer Center to determine appropriate costing and billing of services. Review and revise contract payment terms according to the University of Kansas Cancer Center standard payment term language Conduct a final review of budget and payment terms included in contracts to ensure all agreed upon terms are incorporated Input budget information into the Clinical Trial Management System (CRIS/Velos).

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Work Environment

This position may be eligible for a hybrid work schedule after 6 months. Incumbent will work remotely AND on campus based on a set departmental schedule based on management approval and must reside in the greater Kansas City metropolitan area.

Required Qualifications
  • Work Experience: Three years relevant work experience.
  • Education can be substituted on a year for year basis.
  • Previous working knowledge and experience with research/study budgets.
  • Familiarity of research billing operations for industry, institutional or national group research.
  • Experience analyzing and interpreting legal contracts/documents.
Preferred Qualifications
  • Work Experience: Three or more years of clinical research budget development and negotiation experience.
  • Working knowledge of Medicare Coverage guidelines and FDA regulations relevant to drugs, devices, and biologics.
  • Experience applying knowledge of Medicare Coverage guidelines and FDA regulations relevant to drugs, devices and biologics.
Licenses/Certifications

Professional certification as a clinical research professional or other related certification.

Skills
  • Computer skills including Microsoft Work, Excel and Access applications.
  • Attention to detail with analytical and problem-solving skills.
  • Multi-tasking and time management skills.
  • Interpersonal skills.
  • Communication and negotiation skills.
Required Documents

Cover Letter AND Resume/CV

Comprehensive Benefits Package

Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html

Employee Type

Regular

Time Type

Full time

Rate Type

Salary

Compensation Statement

The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.

Pay Range
  • Pay Range: $60,800.00 - $91,200.00
  • Minimum $60,800.00
  • Midpoint $76,000.00
  • Maximum $91,200.00
Mission

The mission of the University of Kansas Medical Center is to improve lives and communities in Kansas and beyond through innovation in education, research, and health care.

Equal Opportunity/Affirmative Action Employer

The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer.

Equal Opportunity/Affirmative Action

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information.

Disability Preference

Under Kansas state law, certain KUMC positions are subject to disability preference. For positions subject to this requirement, KUMC will offer an interview to a person who has applied for an open position who is qualified, with or without reasonable accommodation, to meet the performance standards of the position and who has presented acceptable proof of disability. If the position you apply for is subject to the disability preference requirement, you will be asked to provide information in support of your request for disability preference when you complete the application for employment.

  • https://civilrights.ku.edu/annual-security-and-fire-safety-report
  • https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf
  • https://www.laborposters.org/federal/1606-federal-pay-transparency-poster.htm
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