This includes an enterprise clinical trials management system, FDA-compliant (21 CFR Part 11 ... Location: Remote Location Position Type: Regular Scheduled Hours: 40 Shift: First Shift Final ...
This includes an enterprise clinical trials management system, FDA-compliant (21 CFR Part 11 ... Location: Remote Location Position Type: Regular Scheduled Hours: 40 Shift: First Shift Final ...
Remote Fda Auditor information
What is a remote FDA auditor?
Remote FDA Auditors are professionals who conduct audits and inspections of facilities, processes, and documentation to ensure compliance with the U.S. Food and Drug Administration (FDA) regulations, but they do so virtually rather than on site. Using digital tools and secure platforms, they review records, interview staff, and assess procedures from a remote location. This approach increases flexibility and efficiency while maintaining the integrity of compliance checks. Remote FDA Auditors are especially vital for organizations in the pharmaceutical, biotech, food, and medical device industries that must adhere to FDA standards.
What are the key skills and qualifications needed to thrive as a remote FDA auditor?
To thrive as a Remote FDA Auditor, you need a deep understanding of FDA regulations, auditing procedures, and quality management systems, typically supported by a degree in life sciences or a related field. Familiarity with electronic audit management tools, documentation systems, and relevant certifications such as Certified Quality Auditor (CQA) are highly valuable. Strong attention to detail, analytical thinking, and effective virtual communication are crucial soft skills for this role. These competencies ensure accurate compliance assessments, clear reporting, and effective collaboration while working remotely.
What are some common challenges faced by remote FDA auditors, and how can they be managed effectively?
Remote FDA Auditors often encounter challenges such as limited access to physical documents, time zone differences with global clients, and ensuring secure communication. To manage these effectively, auditors should familiarize themselves with digital audit tools, establish clear communication protocols with clients, and stay updated on remote auditing best practices. Proactive planning and strong organizational skills are essential for success in this role.
What is the difference between Remote Fda Auditor vs Remote Quality Assurance Specialist?
| Aspect | Remote Fda Auditor | Remote Quality Assurance Specialist |
|---|---|---|
| Certifications | FDA auditor certification, GxP, GMP, GLP | ISO, Six Sigma, GMP, GCP |
| Work Environment | Regulatory agencies, pharmaceutical, biotech companies | Manufacturing, clinical trials, healthcare companies |
| Industry Usage | Primarily in pharma, biotech, medical devices | Broader across healthcare, manufacturing, biotech |
The Remote Fda Auditor focuses on ensuring compliance with FDA regulations through audits of facilities and processes, mainly in pharma and biotech industries. The Remote Quality Assurance Specialist oversees quality systems, policies, and procedures across various healthcare sectors. While both roles require knowledge of GMP and regulatory standards, the Fda Auditor emphasizes compliance verification, whereas the QA Specialist concentrates on maintaining quality standards throughout the organization.
How do you become a remote FDA auditor?
To become a remote FDA auditor, candidates typically need a background in life sciences, healthcare, or quality assurance, along with experience in regulatory compliance. Earning certifications such as RAC or ISO auditor training can enhance prospects, and strong knowledge of FDA regulations and audit procedures is essential. Many roles require prior industry experience and familiarity with remote auditing tools and documentation practices.
What are popular job titles related to Remote Fda Auditor jobs in Ohio?
For Remote Fda Auditor jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching Remote Fda Auditor jobs in Ohio look for?
The top searched job categories for Remote Fda Auditor jobs in Ohio are:
What cities in Ohio are hiring for Remote Fda Auditor jobs?
Cities in Ohio with the most Remote Fda Auditor job openings:
Senior Business Systems Analyst - Comprehensive Cancer Center
Columbus, OH • On-site, Remote
Full-time
Posted 12 days ago
Job description
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact hr-accessibleapplication@osu.edu. If you have questions while submitting an application, please review these frequently asked questions.
Current Employees and Students:
If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process.
Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following:
Job Title:
Senior Business Systems Analyst - Comprehensive Cancer Center
Department:
CCC | Administrative Office
Position Summary
Responsible for daily oversight and operation of CRI-supported applications. Manages troubleshooting, administers and controls user access, conducts access audits, and documents standard operating procedures for application-related processes.
Coordinates with system vendors, clinical research operations, and informatics engineers to test, validate, and implement new or revised modules within Clinical Research Enterprise systems. Assists in updating validation documentation and Standard Operating Procedures to ensure compliance with FDA 21 CFR Part 11 and other applicable regulations. Leads and facilitates cross-functional collaboration with multi-disciplinary teams across the medical center's clinical research enterprise, including information technology, research billing, and clinical trials offices.
Participates in developing strategic plans for system upgrades and implementations across the Clinical Research Informatics environment. This includes an enterprise clinical trials management system, FDA-compliant (21 CFR Part 11) electronic data capture (EDC), eRegulatory binder (eReg), lab information systems, clinical trials matching, integrated electronic medical record (EMR) systems, and EMR functionality that supports clinical trials. Acts as a technical contributor in planning, development, integration, and support of OSUMC Clinical Research Enterprise systems, aligned with the strategic objectives of the research organization and the needs of clinical research stakeholders.
Creates, implements, and maintains formal training manuals and procedures per industry and federal guidance and collaborates with end-user system training team(s) for implementation and updates. Provides guidance and serves as a subject matter expert resource for colleagues.
Oversees the collection of data requirements for research protocol reporting of clinical trial activities, system notifications, and related data visualization tools. Collaborates with data managers and clinical trials subject-matter experts to prepare data for major initiatives and grants, including NIH and NCI.
Must demonstrate excellent oral and written communication, facilitation skills, consensus-building abilities, and the capacity to work independently.
Job Requirements
Bachelor's degree in health science; advanced degree preferred or equivalent combination of education and experience in clinical trials management systems or clinical research operations (such as coordinator, regulatory, auditor, etc.). Four to eight years of relevant clinical experience in a clinical research setting with subject matter expertise in clinical trial workflows and the ability to navigate complex protocols. Expertise in clinical trial data requirements, regulatory affairs, case report form (CRF) development, and protocol development is required. Knowledge of business intelligence tools and report formatting applications (Excel, Tableau, Power BI) is preferred. IT work experience is also preferred; extensive experience in clinical trials or research environments, gathering and understanding technical and end-user requirements, is valuable. Experience developing workflows and user documentation is a plus; knowledge and experience with clinical trial management systems and electronic health records are required.
Requirements of the role include advocacy, interactions with, and knowledge of principal investigator and staff roles within the medical center's clinical research enterprise, as well as engagement with key OSU committees related to the Institutional Review Board (IRB).
Additional Information:
Location:
Remote Location
Position Type:
Regular
Scheduled Hours:
40
Shift:
First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.
Current Employees and Students:
If you are currently employed or enrolled as a student at The Ohio State University, please log in to Workday to use the internal application process.
Welcome to The Ohio State University's career site. We invite you to apply to positions of interest. In order to ensure your application is complete, you must complete the following:
- Ensure you have all necessary documents available when starting the application process. You can review the additional job description section on postings for documents that may be required.
- Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.
Job Title:
Senior Business Systems Analyst - Comprehensive Cancer Center
Department:
CCC | Administrative Office
Position Summary
Responsible for daily oversight and operation of CRI-supported applications. Manages troubleshooting, administers and controls user access, conducts access audits, and documents standard operating procedures for application-related processes.
Coordinates with system vendors, clinical research operations, and informatics engineers to test, validate, and implement new or revised modules within Clinical Research Enterprise systems. Assists in updating validation documentation and Standard Operating Procedures to ensure compliance with FDA 21 CFR Part 11 and other applicable regulations. Leads and facilitates cross-functional collaboration with multi-disciplinary teams across the medical center's clinical research enterprise, including information technology, research billing, and clinical trials offices.
Participates in developing strategic plans for system upgrades and implementations across the Clinical Research Informatics environment. This includes an enterprise clinical trials management system, FDA-compliant (21 CFR Part 11) electronic data capture (EDC), eRegulatory binder (eReg), lab information systems, clinical trials matching, integrated electronic medical record (EMR) systems, and EMR functionality that supports clinical trials. Acts as a technical contributor in planning, development, integration, and support of OSUMC Clinical Research Enterprise systems, aligned with the strategic objectives of the research organization and the needs of clinical research stakeholders.
Creates, implements, and maintains formal training manuals and procedures per industry and federal guidance and collaborates with end-user system training team(s) for implementation and updates. Provides guidance and serves as a subject matter expert resource for colleagues.
Oversees the collection of data requirements for research protocol reporting of clinical trial activities, system notifications, and related data visualization tools. Collaborates with data managers and clinical trials subject-matter experts to prepare data for major initiatives and grants, including NIH and NCI.
Must demonstrate excellent oral and written communication, facilitation skills, consensus-building abilities, and the capacity to work independently.
Job Requirements
Bachelor's degree in health science; advanced degree preferred or equivalent combination of education and experience in clinical trials management systems or clinical research operations (such as coordinator, regulatory, auditor, etc.). Four to eight years of relevant clinical experience in a clinical research setting with subject matter expertise in clinical trial workflows and the ability to navigate complex protocols. Expertise in clinical trial data requirements, regulatory affairs, case report form (CRF) development, and protocol development is required. Knowledge of business intelligence tools and report formatting applications (Excel, Tableau, Power BI) is preferred. IT work experience is also preferred; extensive experience in clinical trials or research environments, gathering and understanding technical and end-user requirements, is valuable. Experience developing workflows and user documentation is a plus; knowledge and experience with clinical trial management systems and electronic health records are required.
Requirements of the role include advocacy, interactions with, and knowledge of principal investigator and staff roles within the medical center's clinical research enterprise, as well as engagement with key OSU committees related to the Institutional Review Board (IRB).
Additional Information:
Location:
Remote Location
Position Type:
Regular
Scheduled Hours:
40
Shift:
First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions.
The university is an equal opportunity employer, including veterans and disability.
About Ohio State University Research Foundation
Sourced by ZipRecruiter
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
Columbus, OH, US