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Clinical Trial Risk Based Monitoring Jobs in Florida

Job Advert Posting ICON's field-based Clinical Trial Liaisons are highly trained site engagement specialists who support clinical trials by providing scientific and clinical support to investigators ...

Monitor the management of and collection of data. * Ensures compliance with the Clinical Trial ... Identify and mitigate quality risk and/or issues associated with assigned studies/activities ...

Monitor the management of and collection of data. * Ensures compliance with the Clinical Trial ... Identify and mitigate quality risk and/or issues associated with assigned studies/activities ...

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. * Conducting site visits to assess site performance ...

To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and ... Monitoring Plans * Vendor Oversight Plans * Recruitment and retention strategies * Study timelines ...

To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and ... Monitoring Plans * Vendor Oversight Plans * Recruitment and retention strategies * Study timelines ...

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Clinical Trial Risk Based Monitoring information

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.

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 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 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 Florida? For Clinical Trial Risk Based Monitoring jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Clinical Trial Risk Based Monitoring jobs in Florida look for? The top searched job categories for Clinical Trial Risk Based Monitoring jobs in Florida are:
What cities in Florida are hiring for Clinical Trial Risk Based Monitoring jobs? Cities in Florida with the most Clinical Trial Risk Based Monitoring job openings:
Home-Based Experienced CRA (Clinical Research Associate)- Bonus/Equity

Home-Based Experienced CRA (Clinical Research Associate)- Bonus/Equity

Medpace, Inc.

Miami, FL • Remote

Other

Medical, Retirement, PTO

Posted 8 days ago


Medpace rating

8.4

Company rating: 8.4 out of 10

Based on 8 frontline employees who took The Breakroom Quiz

14th of 56 rated research


Job description

Job Summary

Experienced Clinical Research Associate (CRA) - join our growing team!

Medpace is growing quickly and we are seeking experienced Clinical Research Associates to join our team. We are an innovative, scientifically oriented mid-sized CRO that is focused on full-service project work.

Through our fast PACE Training Program, you will receive customized, expedited training, and efficient onboarding to familiarize you with Medpace systems.

WE OFFER THE FOLLOWING:

  • Competitive travel bonus;
  • Equity/Stock Option program for high performing CRAs;
  • Annual merit increases;
  • 401K matching;
  • The opportunity to work from home;
  • Flexible work hours across days within a week;
  • Retain airline reward miles and hotel reward points;
  • Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
  • In-house travel agents, reimbursement for airline club, and TSA pre-check;
  • Opportunity for leadership positions/career advancement - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager;
  • Customized Fast PACE training program based on your experience, therapeutic background, and interest;
  • User friendly CTMS with electronic submission and approval of monitoring visit reports;
  • Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
  • In-house administrative support for all levels of CRAs;
  • Opportunities to work with international team of CRAs; and
  • Many additional perks unmatched by other CROs!
Responsibilities
  • Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
  • Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
  • Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
  • Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating  protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
  • On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
  • Verification that the investigator is enrolling only eligible subjects;
  • Regulatory document review;
  • Medical device and/or investigational product/drug accountability and inventory;
  • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
  • Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and
  • Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
Qualifications
  • Clinical Research Associate Experience (minimum 1 year);
  • Ability to travel 60-70% to locations nationwide is required;
  • Must have a minimum of a bachelor's degree in a health or science related field;
  • Proficient knowledge of Microsoft Office;
  • Strong communication and presentation skills; and
  • Must be detail-oriented and efficient in time management.

#LI-Remote

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

  • Cincinnati Campus Overview
  • Flexible work environment
  • Competitive PTO packages, starting at 20+ days
  • Competitive compensation and benefits package
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Community involvement with local nonprofit organizations
  • Discounts on local sports games, fitness gyms and attractions
  • Modern, ecofriendly campus with an on-site fitness center
  • Structured career paths with opportunities for professional growth
  • Discounted tuition for UC online programs

Awards

  • Named a Top Workplace in 2024 by The Cincinnati Enquirer

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Employment Type: OTHER

Medpace logo

About Medpace

Sourced by ZipRecruiter

Medpace is a globally recognized clinicial contract research organization (CRO) based in Cincinnati, OH, in the United States. Established in 1992, it operates in the healthcare sector, providing scientifically-driven outsourcing solutions for the development of drugs and medical devices. It offers comprehensive services like full-service clinical development services, regulatory affairs management, clinical pharmacology, data management, statistical analysis, and medical writing. By applying a scientifically-driven, therapeutically-focused, and patient-centric approach, Medpace's mission is to accelerate the global development of safe and effective medical therapies.

Industry

Medical equipment and supplies manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Cincinnati, OH, US

Year founded

1992