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Irb Director Remote Jobs (NOW HIRING)

Nutrafol

Sr. Clinical Research Manager

$150K - $165K/yr

Direct experience authoring protocols, ICFs, and CRFs * Proven experience managing IRB submissions ... Fully remote work experience * Comprehensive medical, dental, and vision package, including FSA ...

Princeton University

Cloud Engineer

Princeton, NJ · Remote

$59 - $78.75/hr

This is a role for a senior, self-directing engineer who is equally comfortable designing ... Design and operate environments meeting IRB, data governance, and institutional compliance ...

Princeton University

Cloud Engineer

Princeton, NJ · Remote

$59 - $78.75/hr

This is a role for a senior, self-directing engineer who is equally comfortable designing ... Design and operate environments meeting IRB, data governance, and institutional compliance ...

The Rockridge Group

FDA Attorney

Pine Brook, NJ · On-site +1

DIRECT HIRE Firm X, established in 2000, is a national boutique law firm focused exclusively on ... fully remote office. They receive an average of 5 new FDA client inquiries per week.

Emmes

Clinical Research Associate II

Rockville, MD · On-site +1

Overview Clinical Research Associate II US Remote Emmes Group: Building a better future for us all ... We believe the work we do will have a direct impact on patients' lives and act accordingly. We ...

Emmes

Senior Clinical Research Associate

Rockville, MD · On-site +1

Overview Senior Clinical Research Associate US Remote Emmes Group: Building a better future for us ... We believe the work we do will have a direct impact on patients' lives and act accordingly. We ...

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What are some common challenges faced by a remote IRB Director, and how can they be effectively managed?

As a remote IRB Director, one of the main challenges is maintaining clear communication and oversight with board members, researchers, and compliance staff across different locations and time zones. Adopting robust digital collaboration tools and establishing regular virtual meetings can help ensure everyone stays aligned and informed. Additionally, upholding rigorous ethical standards and regulatory compliance remotely requires well-documented processes and an emphasis on thorough training. Staying proactive with updates on federal regulations and fostering a strong virtual team culture are also key to success in this role.

What are the key skills and qualifications needed to thrive as an IRB Director in a remote setting, and why are they important?

To thrive as a remote IRB Director, you need expertise in research ethics, regulatory compliance (e.g., FDA, OHRP regulations), and a strong background in human subjects protection, typically supported by an advanced degree in a relevant field. Familiarity with electronic IRB management systems, regulatory databases, and certifications like CIP (Certified IRB Professional) are commonly expected. Outstanding leadership, attention to detail, and effective virtual communication are crucial soft skills for managing teams and ensuring protocol adherence remotely. These competencies are vital to uphold ethical standards, safeguard research participants, and efficiently oversee review processes in a distributed work environment.

What does an IRB Director do when working remotely?

An IRB Director who works remotely oversees the operations of an Institutional Review Board (IRB), ensuring that research involving human subjects complies with ethical standards and federal regulations. Their responsibilities include reviewing research proposals, coordinating virtual IRB meetings, communicating with researchers, and maintaining documentation. Working remotely, they use digital tools to manage submissions, facilitate communication, and ensure the board’s activities are conducted efficiently and in compliance with all applicable laws.
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Irb Director Remote jobs near you
Infographic showing various Irb Director Remote job openings in the United States as of July 2026, with employment types broken down into 80% Full Time, 17% Part Time, and 3% Contract. Highlights an 3% In-person, and 97% Remote job distribution.
Human Factors Engineer/Usability Engineering - Biopharma Medical Device Remote (JP15469)

Human Factors Engineer/Usability Engineering - Biopharma Medical Device Remote (JP15469)

3 Key Consulting

Thousand Oaks, CA • Remote

$74 - $84/hr

Full-time

Posted 28 days ago

Job description

Job Title: Human Factors Engineer/Usability Engineering - Biopharma Medical Device Remote (JP15469)
Location: Thousand Oaks, CA 91320
Business Unit: Human Factors / Usability Engineering
Employment Type:  Contract
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 08/18/2025
Target start date: 6/15/2026
Pay Rate: $74-84/hr W2 with benefits
Note: This can be fully remote but local to Thousand Oaks, Ca is preferred.
3 Key Consulting is hiring a Human Factors Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
What you will do:
In this vital role you are responsible for supporting HFE/UE planning, research, development and continuous improvement of client’s drug delivery devices using HFE/UE best practices and in accordance with current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries. The Human Factors Engineer / Usability Engineer (HFE/UE) is expected to collaborate with internal and external partners and across functions including engineering, design, commercial, safety, risk, quality, regulatory and market surveillance teams. This person will support human factors research driving innovative, intuitive, and useful products. The HFE will support project study design, HFE/UE methodology, study moderation, data collection, and root cause analysis to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, and product validation in support of regulatory submissions. 
Responsibilities:
The HFE/UE responsibilities include but are not limited to:
  • Work collaboratively with HFE/UE, engineering, design, commercial, and product teams to ensure successful translation of user requirements into products, to create user interface (UI) requirements, that meet the needs of users and enrich the overall user experience across client’s portfolio or programs.
  • Supporting usability activities such as study planning/coordination/management, protocol development, study moderation, data collection, material development, IRB submissions, participant recruitment, data analysis, and HFE/UE design history file documentation to support project needs.
  • Collaborate with the HFE/UE lead to ensure Human-system capabilities and limitations are properly reflected in the system requirements, and HFE/UE input is provided across functions to develop product design, packaging, labeling, and training requirements.  
  • Support appropriate human factors and usability engineering activities to improve the design of products, specifically the device-user interfaces, including the device, packaging, labeling, and instructions for use while minimizing the potential for use errors. 
  • Analyze objective and subjective data from usability studies to inform design, inform risk minimization, and provide alternative design controls/solutions.
  • Support the HFE/UE lead in providing preparation for clinical studies and regulatory submissions in accordance with HFE/UE best practices, guidance and standards.
  • Prepare documentation to support development activities, design controls, DHF, DMR including protocols, task analysis, risk assessment, HFE/UE technical assessments, comparative analysis, HFE/UE reports, data verifications, and regulatory submissions.
  • Actively communicate with internal and external key stakeholders. Exercising critical thinking & educated HFE/UE judgement to determine appropriate next steps/actions.
 
Top Must Have Skills:
1. End to end human factors experience required from planning to validation and reporting
2. Must be able to demonstrate good technical writing skills
3. Good communicate skills and experience working with cross functional teams
4. Minimum experience needed with medical device but most importantly combination product experience
Preferred Qualifications: -
  • Master's degree in Human Factors, HFE/Usability Engineering, or other relevant HF/Engineering discipline and 2+ years of industry experience, working in multi-functional, fast-paced corporate environments.
  • Experience with various HF methodologies such as ethnographic research, interviews, contextual inquiries, focus groups, technical assessments, device UI evaluation, knowledge and comprehension studies, HF professional analysis, task analysis, hazard analysis, risk assessment, formative and summative studies.
  • Experience working directly with users to gather, synthesize and convert user research into concepts that differentiate products in the market, as well as to develop and evaluate new product features, user interfaces and ergonomic designs.
  • Experience using low and high-fidelity prototypes to identify and eliminate potential use errors early in the development process.
  • Experience working in development organizations, particularly virtual development environments contributing to systems design, verification, and validation milestones.
  • Ability to communicate effectively with mechanical, electrical, software, clinical, regulatory, safety, risk, and quality engineering disciplines.
  • The position requires good oral and written communication and organizational skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products.
  • Functional knowledge and experience in the practical application of relevant FDA human factors guidance, regulations and standards, including IEC 62366, AAMI HE75, EN 60601, ISO 14971, MDR, and design controls.

Day to day responsibilities:
Support core development team(s) on all human factors activities, including attending remote meetings, communicating status to manager on all program requests, developing and recommending HFE strategies, and creating and approving HFE documents within Client's document management system.
Red Flags:
No direct experience leading HFE activities for combination product delivery devices. Only has academic research experience. A pattern of changing jobs every year. No medical device or pharmaceutical industry experience.
Interview process:
Candidate has a 25 minute phone interview with hiring manager. Candidate sends HFE writing example (redacted) to hiring manager. Candidate has a 50 minute panel interview. Candidate CV and panel interview results reviewed with senior leadership team. Decision to hire.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.