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Clinical Trial Risk Based Monitoring Jobs in Florida

Sitelabs

Clinical Trial Coordinator

Miami, FL · On-site

$55K - $70K/yr

... whom are based in underserved communities. We believe pharmacy staff should be empowered to ... Monitor site-level metrics including referral volume, lead quality, and enrollment progress ...

Icon plc

Clinical Trial Liaison

Miami, FL

... based research initiatives etc * Capture and elevate critical insights from sites to optimize ... Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data ...

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Clinical Trial Liaison

Tampa, FL

... based research initiatives etc * Capture and elevate critical insights from sites to optimize ... Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data ...

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Clinical Trial Liaison

Jacksonville, FL · On-site

... based research initiatives etc * Capture and elevate critical insights from sites to optimize ... Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data ...

Icon plc

Clinical Trial Liaison

Orlando, FL · On-site

... based research initiatives etc * Capture and elevate critical insights from sites to optimize ... Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data ...

Sitelabs

Clinical Trial Coordinator

Orlando, FL · On-site

$55K - $70K/yr

... whom are based in underserved communities. We believe pharmacy staff should be empowered to ... Monitor site-level metrics including referral volume, lead quality, and enrollment progress ...

SiteLabs

Clinical Trial Coordinator

Miami, FL · On-site

$55K - $70K/yr

... whom are based in underserved communities. We believe pharmacy staff should be empowered to ... Performance Monitoring & Reporting • Track pharmacy activity and recruitment performance using ...

ARTHREX

Clinical Study Manager

Naples, FL

This is an onsite position based at our global headquarters in Naples, Florida. Essential Duties ... Monitor the management of and collection of data. * Ensures compliance with the Clinical Trial ...

Arthrex

Clinical Study Manager

Naples, FL · On-site

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 ...

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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.
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:
Clinical Trial Risk Based Monitoring jobs near you

Clinical Trial Manager, Immunology

SAb Biotherapeutics, Inc

Miami Beach, FL • On-site, Remote

$150K - $165K/yr

Full-time

Posted 17 days ago

Job description

The Clinical Trial Manager (CTM) oversees the planning, implementation and management of clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory guidelines. The CTM plays a critical role in coordinating cross functional teams, maintaining budgets, timelines, and quality standards, and ensuring the successful execution of clinical studies.
Duties and Responsibilities (Responsibilities include but are not limited to):
Study Planning and Execution:
  • Lead the design and implementation of clinical trial protocols, including site selection, patient recruitment strategies, and timeline development.
  • Contributing to the development of study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator Brochures (IBs) and other study-related documents as require
  • Oversee implementation and maintenance of Trial Master File for inspection readiness
Project Management:
  • Manage all aspects of clinical trial operations, ensuring adherence to timelines, budgets, and regulatory requirements.
  • Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)
  • Manage external vendors with oversight of activities
  • Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations
Team Leadership:
  • Collaborate with cross-functional teams including clinical research associates, data managers, and regulatory affairs to ensure successful trial execution.
Site Management:
  • Establish and maintain strong relationships with clinical trial sites. Provide ongoing support and oversight to ensure compliance with protocol and regulatory standards.
Data Integrity and Compliance:
  • Monitor trial progress, ensuring accurate data collection, timely reporting, and adherence to Good Clinical Practice (GCP) guidelines.
Risk Management:
  • Identify potential study risks and develop mitigation strategies to ensure successful trial outcomes.
Communication:
  • Prepare and present updates to stakeholders, including internal teams and external partners. Facilitate regular meetings to discuss study progress and address challenges.
Requirements:
  • B.S. degree with minimum 6-8+ years of experience managing clinical trials in biotech, pharmaceutical
  • Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience
  • Experience with phase II, III study oversight and management
  • Experience with timeline management
  • Strong leadership, effective decision making, and problem-solving skills required
  • Document reviews in relevant systems with a focus on inspection readiness
  • Working knowledge of relevant GCPs and FDA, EMA and MHRA regulations
  • Demonstrated experience using various EDC, CTMS and eTMF (Veeva, Agatha) systems. Experience with operational financial tracking systems a plus
  • Demonstrated proficiency using MS Office applications, including MS Word, Excel, PowerPoint
  • Experience using Smartsheet
  • Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials
  • Excellent written and verbal communication skills
Working Environment and Travel:
Generally accepted office working conditions
Travel up to 25% - ability to travel domestically and internationally
Prefer candidates located in Central or Eastern Time Zones
Physical Requirements:
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee will be able to use a computer for extended periods at any given time. The employee must regularly lift and/or move up to 10 pounds.
ADA:
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB Bio is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB Bio is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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