... remote). * Actively participate in site feasibility assessments and site selection processes ... IRB/EC requirements, and company SOPs. * Prioritize patient safety, ensuring informed consent and ...
... remote). * Actively participate in site feasibility assessments and site selection processes ... IRB/EC requirements, and company SOPs. * Prioritize patient safety, ensuring informed consent and ...
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each ...
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each ...
Remote Irb information
What is a remote IRB?
A Remote IRB, or Institutional Review Board, is a committee that reviews and approves research involving human subjects, but operates remotely rather than in a traditional onsite setting. Remote IRBs allow members to conduct reviews, meetings, and communications online, making the process more flexible and accessible for institutions and researchers across different locations. This setup is especially valuable for multi-site studies or organizations without their own IRB, as it streamlines ethical oversight while ensuring compliance with federal and institutional guidelines.
What is a remote IRB job?
Remote IRB jobs include work as a remote IRB administrator, a remote IRB analyst, and a remote IRB coordinator. Your responsibilities and duties differ depending on your specific position. For example, a remote IRB analyst performs analysis and is responsible for assessing whether or not a study meets all the guidelines and regulatory requirements for the safety and welfare of human subjects. As a remote IRB coordinator, your role is to coordinate internal review board research and compliance during studies. This includes ensuring that test subjects received the proper paperwork and release forms and that studies remain on schedule. You can work from home in any of these positions.
What are the key skills and qualifications needed to thrive as a remote IRB coordinator, and why are they important?
To thrive as a Remote IRB Coordinator, you typically need a background in research ethics, regulatory compliance, and a degree in a related field such as health sciences or public administration. Familiarity with IRB management systems, federal regulations (such as 45 CFR 46), and certifications like CIP (Certified IRB Professional) are often required. Exceptional attention to detail, organizational skills, and effective remote communication are vital soft skills for this role. These competencies are crucial for ensuring ethical research practices, regulatory compliance, and efficient coordination in a remote environment.
What are some common challenges faced by remote IRB coordinators, and how can they be addressed?
Remote IRB Coordinators often face challenges such as ensuring clear communication with research teams across different locations and time zones, navigating complex regulatory requirements, and maintaining thorough documentation electronically. These challenges can be addressed by leveraging secure collaboration tools, establishing regular check-ins with team members, and staying updated on evolving compliance standards. Developing strong organizational habits and participating in ongoing professional development can also make it easier to manage the demands of a remote IRB role.
What is the difference between Remote Irb vs Remote Clinical Research Coordinator?
| Aspect | Remote Irb | Remote Clinical Research Coordinator |
|---|---|---|
| Required Credentials | IRB approval, research ethics knowledge | Clinical research experience, regulatory knowledge |
| Work Environment | Review boards, ethics committees, administrative | Study sites, patient interaction, data management |
| Employer & Industry Usage | Hospitals, research institutions, biotech firms | Pharmaceutical companies, CROs, hospitals |
| Common Search & Comparison | Yes | No |
The Remote Irb role focuses on reviewing research protocols for ethical compliance, requiring knowledge of research ethics and IRB procedures. In contrast, a Remote Clinical Research Coordinator manages study operations, patient recruitment, and data collection. While both roles are integral to clinical research, they differ in responsibilities, credentials, and work environment.
More about Remote Irb jobs
What are the most commonly searched types of Irb jobs in Indiana?
The most popular types of Irb jobs in Indiana are:
What are popular job titles related to Remote Irb jobs in Indiana?
For Remote Irb jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Remote Irb jobs in Indiana look for?
The top searched job categories for Remote Irb jobs in Indiana are:
What cities in Indiana are hiring for Remote Irb jobs?
Cities in Indiana with the most Remote Irb job openings:
Full-time
Medical, Life
Posted 12 days ago
BD rating
7.2
Based on 142 frontline employees who took The Breakroom Quiz
324th of 494 rated machine equipment manufacturers
Job description
As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job DescriptionSummary:
The Senior Clinical Research Associate (Sr. CRA) is an experienced clinical operations professional responsible for managing site monitoring and relationship activities across multiple clinical studies. This role serves as a key resource to study teams, ensuring high-quality study execution, adherence to Good Clinical Practice (GCP), regulatory requirements, and company standards. The Sr. CRA provides guidance to less experienced CRAs, supports investigator sites, proactively identifies and resolves operational issues, and contributes to the successful delivery of clinical study objectives.
The Sr. CRA will practice excellent written and verbal communication skills, including medical terminology. In this role the candidate will display strong presentation, organizational, timemanagement, and prioritization skills. Being technically savvy with the ability to leverage technology to drive efficiency and performance while working independently with minimal supervision in a fastpaced environment will be key.
Responsibilities:
Study & Site Management
Serve as CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and closeout activities (onsite, virtual, remote).
Actively participate in site feasibility assessments and site selection processes.
Ensure study conduct is executed according to the clinical protocol, regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs.
Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically.
Review and report AEs/SAEs and protocol deviations in accordance with regulatory and company requirements.
Maintain complete, accurate, and auditready regulatory documentation and TMFs in accordance with ALCOA principles.
Monitor site inventory of investigational products and study supplies.
Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance.
Monitoring & Documentation
Author, review, and approve Monitoring Plans, study source documents, monitoring tools, and sitefacing training materials.
Perform SDR/SDV per monitoring plans and document monitoring activities through timely, highquality trip reports.
Ensure compliance with company travel and expense policies.
Leadership & Mentorship
Provide mentoring, training, and functional oversight of CRAs, including contingent (contract) CRAs.
Lead or review functional job aids and training materials.
Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues.
Systems & Collaboration
Utilize and maintain accurate study data in clinical systems, including Veeva Vault CTMS and CDMS.
Work crossfunctionally with internal teams and CROs to ensure highquality study execution and oversight.
Build and maintain effective working relationships with investigator sites and internal stakeholders.
Minimum Qualifications
Bachelor's degree or higher in a healthcare or sciencerelated field. (Alternate education levels may be considered based on experience and business need)
3 years of fieldbased CRA experience in the medical device and/or pharmaceutical industry.
Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management.
Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA.
Preferred Knowledge & Skills
Experience with IVD and/or POC studies.
Laboratory experience in molecular biology, microbiology, or blood culture.
Proficiency with Veeva Vault CTMS and CDMS
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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Primary Work LocationUSA MD - Sparks - 7 Loveton CircleAdditional LocationsWork ShiftNA (United States of America)At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
About BD
Sourced by ZipRecruiter
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Industry
Medical equipment and supplies manufacturing and manufacturing
Company size
10,000+ Employees
Headquarters location
Franklin Lakes, NJ, US