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Clinical Trial Risk Based Monitoring Jobs in Connecticut

... ongoing monitoring of trial data and contribution to Data Safety Monitoring Board materials ... Actual pay will be determined based on experience, qualifications, location, and other job-related ...

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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 Connecticut?

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

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

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

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

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

Clinical Application Specialist

TECLens

Stamford, CT

Full-time

Re-posted 22 days ago


Job description

 Clinical Application Specialist

Company:

TECLens is a small medical technology company with an entrepreneurial mindset and culture. We dream up and invent transformational solutions to vision care challenges facing hundreds of millions of people. We are looking for highly skilled, motivated, creative and dependable contributors to join our team.

Position Description:

Clinical field team member responsible for providing on-site medical and technical support at clinical trial sites. This role serves as the primary liaison between TECLens and clinical investigators, ensuring proper device operation, protocol compliance, and optimal patient outcomes.

Compensation:

Competitive, commensurate with experience. Details available upon request.

Location and Travel:

  • Remote / Home Office (US-based)
  • Up to 90% of international travel to clinical sites (Latin America, Asia/Pacific)
  • Must possess valid US passport

General Candidate Description:

  • Clinical professional with experience in ophthalmology or optometry environments and hands-on patient care 
  • Comfortable working independently in international clinical environments with minimal supervision
  • Strong interpersonal skills with ability to build relationships with physicians, clinical staff, and patients across diverse cultures
  • Adaptable problem solver with enough technical background to troubleshoot issues in real-time during clinical procedures
  • Excellent communicator who can translate technical concepts for clinical audiences
  • Self-starter comfortable with extensive travel and variable schedules

Background:

TECLens (www.TECLens.com) is developing a completely novel vision correction technology based on quantitative corneal crosslinking, or qCXL™. The qCXL™ system has 4 primary components:

  • A single use disposable therapy delivery device that delivers therapeutic ultraviolet light (UV) and treatment monitoring ultrasound (US)
  • A user interface console that houses the controlling computer and the UV and US systems
  • A photoactive drug that interacts with the UV to provide corneal strengthening that results in refractive change
  • A computational treatment planning suite (TPS) that calculates an optimized plan for each patient's specific needs and provides a control point that the US system monitors during the procedure

The Clinical Application Specialist will be present at clinical sites during site training and patient treatments to ensure proper system setup, assist clinical staff with device operation, monitor protocol compliance, and provide real-time troubleshooting support.

Responsibilities:

  • Provide On-Site Support at clinical trial sites during all patient treatment procedures
  • Train and Support clinical investigators and site staff on proper CXLens system setup, operation, and patient preparation
  • Ensure Protocol Compliance by monitoring adherence to study procedures and documentation requirements
  • Troubleshoot device and procedural issues in real-time during clinical treatments
  • Communicate with TECLens engineering and clinical teams to report site feedback, device performance, and any adverse events
  • Document site visit reports, training records, and clinical observations
  • Assist with scleral lens fitting assessments and patient preparation procedures
  • Support regulatory inspections and site audits as needed
  • Monitor inventory of clinical supplies and coordinate shipments to study sites
  • Build Relationships with clinical investigators and site coordinators to ensure smooth study operations

Ideal Candidate:

OD (Doctor of Optometry) with scleral contact lens fitting experience or prior medical liaison experience, such as ophthalmology/optometric technician or

BS in Engineering, Engineering Technology, or related technical field with 3+ years clinical ophthalmology/optometry experience

Additional Qualifications:

  • Experience with scleral lens fitting and assessment highly desirable
  • Direct experience with corneal topography, pachymetry, or other ophthalmic diagnostic equipment strongly preferred
  • Prior experience supporting clinical trials or medical device field support preferred
  • Working knowledge of GCP (Good Clinical Practice) and clinical trial operations desirable
  • Spanish and/or Portuguese language skills a plus
  • Comfortable with extended international travel and working across multiple time zones
  • Strong English written and verbal communication skills
  • Proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, and PowerPoint

TECLens logo

About TECLens

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

1 - 10 Employees

Headquarters location

Stamford, CT, US

Year founded

2013