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Clinical Trial Risk Based Monitoring Jobs in Michigan

ICON

Clinical Research Associate II

Detroit, MI · On-site +1

What You Will Do: You will contribute to clinical trial monitoring activities, taking ... based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package ...

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Clinical Trial Risk Based Monitoring information

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 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 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.

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.
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Clinical Trial Risk Based Monitoring jobs near you
Clinical Research Registered Nurse

Clinical Research Registered Nurse

McLaren Health Care Corporation

Detroit, MI • On-site

Full-time

Posted 20 days ago

McLaren Health Care rating

6.7

Company rating: 6.7 out of 10

Based on 211 frontline employees who took The Breakroom Quiz

522nd of 877 rated healthcare providers

Job description

Department: Clinical Research (RN position - Detroit)
Scheduled Bi-Weekly Hours: 80
Shift: Full-Time Days
Daily Work Times: 8:00am-4:30pm
Position Summary:
The CRN is a member of the clinical research team and assists in the recruitment, compliance and follow-up of patients that are eligible for, or registered to a clinical trial. The CRN provides specialized nursing care that ensures exceptional, ethical, safe care yielding high-quality data. Responsible for managing patient standard of care needs as well as participant and protocol needs through application of independent judgment, communication and collaboration with the research patient, patient's family, ancillary/support services, the physician, and the clinical research team.
Responsibilities:
  1. Provides clinical trial support to ensure patients are offered appropriate clinical trials following Good Clinical Practice standards.
  2. Assesses, monitors, evaluates, and documents the patient's compliance and response to protocol treatment
  3. Provides leadership to other members of the clinical team by articulating expected standards of care as directed by the clinical trial. Delegates and supervises other employees, as assigned, to ensure that the clinical trial plan is carried out and that established outcomes are achieved.
  4. Participates in process improvement activities of the department to ensure patient safety.
  5. Demonstrates professionalism and a commitment to improving the work environment through participation in meetings, timely and effective communication, and an embracement of cultural diversity
  6. Provides clinical research support staff with the documentation needed to determine eligibility and maintain compliance

Required
  • Associate Degree from an accredited Nursing program
  • Current State of Michigan Registered Nurse license
  • Two years of nursing experience

Preferred
  • Research experience in designated area of work
  • Nursing experience in area of clinical research focus

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