Clinical SME I
Herndon, VA · On-site
Review and analyze clinical trial protocols and regulatory documentation. * Provide guidance on FDA ... Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with ...
Clinical SME I
Herndon, VA · On-site
Review and analyze clinical trial protocols and regulatory documentation. * Provide guidance on FDA ... Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with ...
Clinical SME I
Herndon, VA · Remote
Review and analyze clinical trial protocols and regulatory documentation. * Provide guidance on FDA ... Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with ...
Clinical SME I
Herndon, VA · Remote
Review and analyze clinical trial protocols and regulatory documentation. * Provide guidance on FDA ... Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with ...
Clinical SME I
Herndon, VA · Remote
Review and analyze clinical trial protocols and regulatory documentation. * Provide guidance on FDA ... Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with ...
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Clinical SME I
Herndon, VA · Remote
Review and analyze clinical trial protocols and regulatory documentation. * Provide guidance on FDA ... Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with ...
The Clinical Trial Coordinator will support the operational, regulatory, and administrative ... for monitoring visits, audits, and inspections. Communication and Collaboration * Serve as a ...
The Clinical Trial Coordinator will support the operational, regulatory, and administrative ... for monitoring visits, audits, and inspections. Communication and Collaboration * Serve as a ...
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Reviewing the performance dashboards and other clinical trial systems to oversee site and patient ... Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
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Reviewing the performance dashboards and other clinical trial systems to oversee site and patient ... Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Reviewing the performance dashboards and other clinical trial systems to oversee site and patient ... Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
Reviewing the performance dashboards and other clinical trial systems to oversee site and patient ... Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
Reviewing the performance dashboards and other clinical trial systems to oversee site and patient ... Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
Reviewing the performance dashboards and other clinical trial systems to oversee site and patient ... Employing strategic thinking and problem-solving skills to propose and implement risk mitigations.
Part-time Clinical Research Coordinator 3; Center for Psychiatric Clinical Research
Charlottesville, VA · On-site
$24 - $32/hr
... trial conduct and demonstrate a solid understanding of clinical research compliance. The CRC will ... This position is based in Charlottesville, VA, and must be performed fully on-site. About UVA and ...
Part-time Clinical Research Coordinator 3; Center for Psychiatric Clinical Research
Charlottesville, VA · On-site
$24 - $32/hr
... trial conduct and demonstrate a solid understanding of clinical research compliance. The CRC will ... This position is based in Charlottesville, VA, and must be performed fully on-site. About UVA and ...
... clinical trial agreement.Maintain compliance with allowable costs, period of performance ... Monitors and meets allinternal and Sponsor stipulated deadlines and content requirements. Ensures ...
... clinical trial agreement.Maintain compliance with allowable costs, period of performance ... Monitors and meets allinternal and Sponsor stipulated deadlines and content requirements. Ensures ...
Monitor participant progress, behavioral observations, and adverse events throughout clinical ... Record and maintain patient data using electronic and paper-based systems * Collaborate with ...
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Monitor participant progress, behavioral observations, and adverse events throughout clinical ... Record and maintain patient data using electronic and paper-based systems * Collaborate with ...
Clinical Research Coordinator 2; Plastic Surgery
Charlottesville, VA · On-site
$24 - $32/hr
This position coordinates and implements clinical trial research studies, works closely with the ... This position is based in Charlottesville, VA, and must be performed fully on-site. About UVA and ...
Clinical Research Coordinator 2; Plastic Surgery
Charlottesville, VA · On-site
$24 - $32/hr
This position coordinates and implements clinical trial research studies, works closely with the ... This position is based in Charlottesville, VA, and must be performed fully on-site. About UVA and ...
Using the latest progressive medical research and evidence based treatments we are passionate about ... Perform clinical safety assessments and monitoring for study trial participation to include such ...
Using the latest progressive medical research and evidence based treatments we are passionate about ... Perform clinical safety assessments and monitoring for study trial participation to include such ...
Using the latest progressive medical research and evidence based treatments we are passionate about ... Perform clinical safety assessments and monitoring for study trial participation to include such ...
Using the latest progressive medical research and evidence based treatments we are passionate about ... Perform clinical safety assessments and monitoring for study trial participation to include such ...
Clinical Data Manager 2
Reston, VA · On-site
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Clinical Data Manager 2
Reston, VA · On-site
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Clinical Data Manager
Reston, VA · On-site
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
Clinical Data Manager
Reston, VA · On-site
Test clinical trial databases and data entry screens assuring compliance with protocol and ... Prepare, review, and submit clinical data to monitoring agencies * Maintain client communication ...
AI Compliance Monitoring & Audit Advisor
$100K - $165K/yr
Establish risk-based monitoring plans aligned to regulatory requirements and AI governance priorities. * Oversee end-to-end engagement lifecycle: planning, testing, issue identification, and ...
AI Compliance Monitoring & Audit Advisor
$100K - $165K/yr
Establish risk-based monitoring plans aligned to regulatory requirements and AI governance priorities. * Oversee end-to-end engagement lifecycle: planning, testing, issue identification, and ...
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?
| Aspect | Clinical Trial Risk Based Monitoring | Clinical Trial Data Manager |
|---|---|---|
| Primary Focus | Monitoring trial sites for risks and compliance | Managing and ensuring accuracy of trial data |
| Required Skills | Monitoring protocols, regulatory knowledge, site management | Data management, database systems, quality control |
| Work Environment | Clinical sites, monitoring visits, remote oversight | Data centers, clinical trial databases, office setting |
| Certifications | GCP, monitoring certifications | CDMP, 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 Virginia? For Clinical Trial Risk Based Monitoring jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Clinical Trial Risk Based Monitoring jobs in Virginia look for? The top searched job categories for Clinical Trial Risk Based Monitoring jobs in Virginia are:
What cities in Virginia are hiring for Clinical Trial Risk Based Monitoring jobs? Cities in Virginia with the most Clinical Trial Risk Based Monitoring job openings:
Full-time
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Job description
Position Title
Clinical SME I
Overview
We are seeking a Clinical Subject Matter Expert (SME) with extensive experience in clinical trial operations, FDA regulatory processes, and protocol development. The ideal candidate will provide scientific and regulatory expertise supporting clinical research and healthcare initiatives.
Key Responsibilities
Required Qualifications
Required Skills
Preferred Qualifications
Clinical SME I
Overview
We are seeking a Clinical Subject Matter Expert (SME) with extensive experience in clinical trial operations, FDA regulatory processes, and protocol development. The ideal candidate will provide scientific and regulatory expertise supporting clinical research and healthcare initiatives.
Key Responsibilities
- Review and analyze clinical trial protocols and regulatory documentation.
- Provide guidance on FDA regulatory requirements and ICH guidelines.
- Support protocol development, study design, and safety review processes.
- Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments.
- Collaborate with clinical, regulatory, and technical teams.
- Assist in pharmacovigilance and informed consent review activities.
- Provide subject matter expertise for healthcare and clinical research initiatives.
- Ensure compliance with applicable federal and clinical research regulations.
Required Qualifications
- Advanced degree preferred:
- MD
- PharmD
- RN
- MPH
- MS in Clinical Research
- Related clinical/scientific discipline
- Minimum 10 years of relevant clinical research or regulatory experience.
- Deep understanding of:
- Clinical trial protocols
- FDA regulatory review processes
- Drug development lifecycle
- Safety review
- Protocol design
Required Skills
- Clinical protocol review
- ICH guidelines
- FDA regulatory processes
- Pharmacovigilance
- Study design
- Endpoint analysis
- Risk-benefit evaluation
- Informed consent review
Preferred Qualifications
- RAC (Regulatory Affairs Certification)
- Active clinical licensure preferred.
About Oran
Sourced by ZipRecruiter
Industry
It services
Company size
11 - 50 Employees
Headquarters location
Herndon, VA, US
Year founded
2004