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Clinical Trial Risk Based Monitoring Jobs in Michigan

Meet regularly with team members collectively, as well as on an individual basis to monitor ... plan based on the level and/ortype.Compensationranges for the position are below: Pay Type

Meet regularly with team members collectively, as well as on an individual basis to monitor ... plan based on the level and/or type. Compensation ranges for the position are below: Pay Type

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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 Michigan?

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

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

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

RN - Clinical Oncology Research Coordinator- RN

Henry Ford Health System

Dearborn, MI • On-site

Other

Medical, Dental, Vision

This job post has expired today. Applications are no longer accepted.


Henry Ford Health rating

7.0

Company rating: 7.0 out of 10

Based on 565 frontline employees who took The Breakroom Quiz

414th of 888 rated healthcare providers


Job description

GENERAL SUMMARY:

Using established procedures, perform assessments independently and in collaboration with the physician investigator to ensure that the objectives of an established oncology research protocol are met and in compliance with IRB and sponsor guidelines. Identify and recruit patients into oncology clinical trials. Facilitate clinical testing and check results to determine patient eligibility for a clinical trial. Coordinate patient care across multiple departments/ disciplines, ensuring that the treatment adheres to both strict protocol timelines and the critical clinical timeline that is based on the specific patient scenario/diagnosis. Responsible for providing education regarding diagnosis, clinical trial, and investigational chemotherapy to patients and their families. Responsible for nursing oversight of the investigational chemotherapy treatment. Ensure that chemotherapy orders are written according to the dosing guidelines defined by the clinical trial. Responsible for checking the safety parameters and initiating treatment when patients present for chemotherapy. Triage all patient clinical needs, including immediate and delayed reactions from the investigational agent, which often requires coordination with the patient's primary care physician and external institutions. Initiate direct admissions to the hospital, and referrals to Behavioral Health, Homecare and/or Hospice as appropriate. Support physician investigators and other clinicians as necessary to facilitate patient participation and compliance in oncology. Provide educational in-services on investigational chemotherapy and clinical trial compliance measures to infusion nurses, inpatient staff and other departments as necessary.

EDUCATION/EXPERIENCE REQUIRED:

  • Current valid Michigan RN license required.

  • OCN certification required within three (3) years of hire into the position. ACRP or SOCRA certification preferred. T

  • wo (2) years of progressive oncology research experience preferred.

  • Ability to utilize computer software to access and input data.

Additional Information

  • Organization: Henry Ford Medical Group

  • Department: Cancer Clinical & Trans Resear

  • Shift: Day Job

  • Union Code: Not Applicable

    Additional Details

This posting represents the major duties, responsibilities, and authorities of this job, and is not intended to be a complete list of all tasks and functions. It should be understood, therefore, that incumbents may be asked to perform job-related duties beyond those explicitly described above.

Overview

Henry Ford Health partners with millions of people on their health journey, across Michigan and around the world. We offer a full continuum of services – from primary and preventative care to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other health care retail. With former Ascension southeast Michigan and Flint region locations now part of our team, Henry Ford’s care is available in 13 hospitals and hundreds of ambulatory care locations. Based in Detroit, Henry Ford is one of the nation’s most respected academic medical centers and is leading the Future of Health: Detroit, a $3 billion investment anchored by a reimagined Henry Ford academic healthcare campus. Learn more at henryford.com/careers .

Benefits

The health and overall well-being of our team members is our priority. That’s why we offer support in the various components of our team’s well-being: physical, emotional, social, financial and spiritual. Our Total Rewards program includes competitive health plan options, with three consumer-driven health plans (CDHPs), a PPO plan and an HMO plan. Our team members enjoy a number of additional benefits, ranging from dental and eye care coverage to tuition assistance, family forming benefits, discounts to dozens of businesses and more. Employees classified as contingent status are not eligible for benefits.

Equal Employment Opportunity/Affirmative Action Employer

Equal Employment Opportunity / Affirmative Action Employer Henry Ford Health is committed to the hiring, advancement and fair treatment of all individuals without regard to race, color, creed, religion, age, sex, national origin, disability, veteran status, size, height, weight, marital status, family status, gender identity, sexual orientation, and genetic information, or any other protected status in accordance with applicable federal and state laws.

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About Henry Ford Health

Sourced by ZipRecruiter

Henry Ford Health provides a full continuum of services from Primary and Preventative care, to Complex and Cpecialty care, Health Insurance, a full suite of home health offerings, Virtual care, Pharmacy, Eye care and other Healthcare retail. It is one of the Nation’s leading Academic Medical Centers, recognized for Clinical excellence in Cancer care, Cardiology and Cardiovascular Surgery, Neurology and Neurosurgery, Orthopedics and Sports medicine, and Multi organ transplants. Consistently ranked among the top five NIH funded institutions in Michigan, Henry Ford Health engages in more than 2,000 research projects annually. Equally committed to educating the next generation of Health Professionals, Henry Ford Health trains more than 4,000 Medical students, Residents and fellows every year across 50+ accredited programs. With more than 33,000 valued team members, Henry Ford Health is also among Michigan’s largest and most Diverse employers, including nearly 6,000 physicians and researchers from the Henry Ford Medical Group, Henry Ford Physician Network and Jackson Health Network.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Detroit, MI, US

Year founded

1915