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Clinical Trial Risk Based Monitoring Jobs in Iowa

Zimmer Biomet

$14.75 - $19.75/hr

... Clinical Trial Management System (CTMS). How You'll Create Impact * Assist in testing and ... Help monitor and track system issues, assisting in troubleshooting with supervision. * Perform ...

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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 Iowa?

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

What job categories do people searching Clinical Trial Risk Based Monitoring jobs in Iowa look for?

The top searched job categories for Clinical Trial Risk Based Monitoring jobs in Iowa are:

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

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

Clinical Trial Risk Based Monitoring jobs near you

Clinical/HC Research Specialist - Cardiology

The University Of Iowa

Iowa City, IA • On-site

Full-time

Re-posted 12 days ago

University Of Iowa rating

6.9

Company rating: 6.9 out of 10

Based on 85 frontline employees who took The Breakroom Quiz

464th of 629 rated colleges and universities

Job description

BASIC FUNCTION:

Apply clinical skills requiring specialized licensing to independently deliver and evaluate research protocols. The position requires the academic knowledge of a very specialized team and professional licensure in a clinically-related field related to the study.  Key areas of responsibility include research/clinical activities, protocol development and study responsibilities, subject recruitment and enrollment, data collection and monitoring, regulatory guidelines and documents, human resources/leadership and financial responsibility. This role also includes direct patient care involving conducting follow up visits with patients and performing assessments required per protocol.

KEY AREAS OF RESPONSIBILITY:

Research/Clinical Activities:

  • Perform clinical/health care research activities and functions as a specialist/technical expert in electrophysiology.

  • Coordinate the care of research participants according to protocols requiring a high level of judgment and independent action.

  • Review new protocols and assign protocols to staff.

Protocol Development and Study Responsibilities:

  • Develop, edit, coordinate, manage and maintains specialized electrophysiology study protocols.

  • Establish study-related metrics for efficiency and success.

  • Prepare, evaluate and analyze reports.

  • Review aggregate data from query resolutions and monitor visit reports for all studies.

  • Responsible for site management and daily activities associated with a clinical trial.

  • Provide training and guidance; organize and facilitate meetings.

  • Communicate to health care practitioners, agencies and sponsors.

Subject Recruitment and Enrollment:

  • Function as specialized/technical expert in electrophysiology; perform clinical and data coordination functions associated with subject recruitment, enrollment and data collection.

  • Coordinate the care of research participants according to protocols requiring a high level of judgment and direct patient care.

Data Collection and Monitoring:

  • Evaluate and analyze data collection procedures.

  • Update and maintain the requirements and specifications for the electronic data capture systems.

Regulatory Guidelines and Documents:

  • Manage safety of subjects/patients.

  • Assume responsibility for reportable events reporting, and any corrective actions taken. 

  • Manage and organize regulatory documentation.

  • Prepare regulatory submissions.

  • Perform on-site audits of research and clinical data.

  • Communicate with IRB staff and investigators.

Human Resources/Leadership:

  • May hire, develop and manage the performance of staff; assure staff is complaint with UI policies and procedures.

Financial Responsibility:

  • Perform administrative tasks to assure completion within specific timelines and budgets.

  • Develop and administer budget for study(ies).

REQUIRED QUALIFICATIONS:

  • A Master's degree in Nursing or an equivalent combination of education and experience is required.

  • 3 years of related experience is required.

  • Excellent written and verbal communication skills are required.

  • A current, valid Iowa Registered Nurse license is required.

  • Demonstrated knowledge of effective strategies for working with faculty, staff, and students from a variety of backgrounds and perspectives.

DERSIRABLE QUALIFICATIONS:

  • Experience with clinical trials is desired.

  • Good clinical practice training.

Position and Application Details:

In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:

  • Resume
  • Cover Letter

Job openings are posted for a minimum of 7 calendar days and may be removed from posting and filled any time after the original posting period has ended.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.

For additional questions, please contact ashley-rayer@uiowa.edu.

Additional Information
  • Classification Title: Clinical/HC Research Spec
  • Appointment Type: Professional and Scientific
  • Schedule: Full-time
Compensation
  • Pay Level: 6A
Contact Information
  • Organization: Healthcare
  • Contact Name: Ashley Nelson
  • Contact Email: ashley-rayer@uiowa.edu

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