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Irb Assistant Jobs in Silver Spring, MD (NOW HIRING)

Clinical Research Assistant

Fairfax, VA ยท On-site

$46K - $96K/yr

The Clinical Research Assistant will perform a variety of duties involved in the collection ... Responsible for submissions and reports to the IRB; maintains documentation of IRB communications ...

Protocol Navigator

Bethesda, MD ยท On-site

$21 - $27.75/hr

Keep up with IRB and ORSC Policies and SOPs. * Support interactions with FDA Regulatory Managers (when applicable). * Assist in responding to stipulations (when applicable). * Assist with preparing ...

Keep up with IRB and ORSC Policies and SOPs. * Support interactions with FDA Regulatory Managers (when applicable). * Assist in responding to stipulations (when applicable). * Assist with preparing ...

Protocol Navigator

Bethesda, MD ยท On-site

$21 - $27.75/hr

Keep up with IRB and ORSC Policies and SOPs. * Support interactions with FDA Regulatory Managers (when applicable). * Assist in responding to stipulations (when applicable). * Assist with preparing ...

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Irb Assistant information

What is an IRB assistant?

IRB Assistants are administrative professionals who support Institutional Review Boards (IRBs), which oversee research involving human subjects to ensure ethical standards are met. Their responsibilities often include preparing and processing documentation, maintaining records, assisting in the review process, and communicating with researchers about compliance requirements. They help ensure that research proposals adhere to federal, state, and institutional regulations and facilitate the efficient operation of the IRB. IRB Assistants play a vital role in protecting the rights and welfare of research participants and maintaining the integrity of the research process.

What skills and qualifications are needed to thrive as an IRB assistant?

To thrive as an IRB Assistant, you need a solid understanding of research ethics, regulatory compliance, and administrative procedures, often supported by a bachelor's degree in a related field. Familiarity with electronic submission systems, database management, and documentation software is typically required. Attention to detail, organizational skills, and effective communication are crucial soft skills for this role. These skills ensure the protection of human subjects, accurate record-keeping, and efficient support of the Institutional Review Board's operations.

What are common challenges faced by an IRB assistant and how can they be managed?

IRB Assistants often encounter challenges such as managing multiple protocol submissions simultaneously, staying updated on evolving regulatory requirements, and ensuring timely communication between researchers and board members. To effectively manage these challenges, strong organizational skills and attention to detail are essential, along with a proactive approach to learning about updates in human research protections. Building collaborative relationships with both researchers and IRB staff can also help streamline processes and foster a supportive work environment.

What is the difference between Irb Assistant vs Clinical Research Coordinator?

AspectIrb AssistantClinical Research Coordinator
CredentialsHigh school diploma or associate's; some roles may require certificationBachelor's degree often preferred; certifications like CCRP beneficial
Work EnvironmentOffice and clinical settings, supporting IRB processesClinical sites, hospitals, or research centers managing studies
Employer & IndustryResearch institutions, hospitals, universitiesPharmaceutical companies, research organizations, hospitals
Job FocusAssisting with IRB submissions, documentation, complianceOverseeing study coordination, patient recruitment, data collection

The Irb Assistant primarily supports IRB-related tasks such as documentation and compliance, often requiring less extensive education. In contrast, a Clinical Research Coordinator manages the overall conduct of clinical trials, including patient interactions and data management. Both roles are essential in research but differ in scope and responsibilities.

What are the most commonly searched types of Irb jobs in Silver Spring, MD?

The most popular types of Irb jobs in Silver Spring, MD are:

What are popular job titles related to Irb Assistant jobs in Silver Spring, MD?

For Irb Assistant jobs in Silver Spring, MD, the most frequently searched job titles are:

What cities near Silver Spring, MD are hiring for Irb Assistant jobs?

Cities near Silver Spring, MD with the most Irb Assistant job openings:

Infographic showing various Irb Assistant job openings in Silver Spring, MD as of August 2026, with employment types broken down into 84% Full Time, and 16% Part Time. Highlights an 100% In-person job distribution.

Senior Regulatory Analyst (HS/IRB) (Part-Time)

Rockville, MD โ€ข On-site, Remote

Ripple Effect
Business Management Consultingย โ€ขย 51 - 200 employees

$49.23 - $56.62/hr

Part-time

Posted yesterday

New


Job description

  • Job Code: SHR-RA-04T
  • Location:ย Ripple Effect Headquarters - Rockville, MDย 
  • Employee Type:ย Exempt, Part-Time Regular
  • Telework: Full-time (this role is fully remote with a preference for local, or within local driving distance to HHS badging location)
  • Clearance:ย Public Trust
  • Salary Range:ย $49.23 - $56.62 per hourย (how weย pay and promote)ย 

Are you passionate about bridging science and strategy to drive progress forward? Are you interested in helping ensure that human subjects research is conducted ethically and in compliance with federal regulations?

Ripple Effect is seeking aย Senior Regulatory Analyst (HS/IRB)ย to support the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services (HHS). In this role, you will support OHRP's compliance oversight mission by reviewing complaints, incident reports, and institutional submissions related to human subjects research. You will assist with the evaluation of compliance matters, conduct preliminary assessments, review regulatory documentation, and support case management activities involving Institutional Review Boards (IRBs), research institutions, and investigators. Additionally, you will apply your knowledge of the Common Rule (45 CFR 46), human research protections, and research compliance requirements to identify potential issues, support compliance reviews, and help develop recommendations for leadership consideration. Strong attention to detail, analytical thinking, and written communication skills are essential as you help maintain accurate records, prepare reports, and support the protection of research participants across a diverse research landscape.

If this position sounds of interest, there's a place for you here atย Ripple Effect! We offer a diverse and engaging work environment, meaningful opportunities to support an important public health mission, and flexible work options that support your lifestyle and professional growth.

Responsibilitiesย 

  • Technical Execution:ย Be the first point of contact for communications between internal and external parties. Receive and review complaints and incident report documents for completeness, accuracy, potential participant safety concerns, and regulatory significance
  • Communication and Documentation: Provide preliminary assessment for complaints and incident reports to agency leadership. Draft correspondence, information requests, case summaries, briefing materials, and status reports. Communicate professionally with research institutions, IRB personnel, investigators, complainants, and government officials. Request and collect additional information necessary to support compliance evaluations. Present analyses and recommendations to supervisors and compliance review teams. Participate in internal case review meetings and support leadership reporting activities, Develops a wide range of deliverables including reports, communication logs, trackers, briefing decks, and training materials, ensuring clarity and consistency.ย 
  • Schedule and Timelines: Track case status, milestones, correspondence, and required follow-up activities. Ensure records management practices support transparency, quality assurance, and audit readiness.
  • Quality Management: Ensures deliverables meet quality standards and guidelines for format, content, and accessibility, and contributes to continuous improvement efforts.ย 
  • Regulatory Compliance and Data Analysis: Applies working knowledge of regulatory and contractual requirements and contributes to content development and compliance procedures for the agency, Assist in monitoring and communicating institutional corrective actions and resolution of compliance matters, Analyze research documentation, IRB records, investigator information, institutional responses
  • Problem Solving & Continuous Improvement: Contributes to new processes and procedures to enhance team effectiveness andย efficiency andย proposes solutions to complex issues.ย 
  • Supervision:ย Works under general direction, executes assignments independently, and keeps supervisor updated.ย 
  • Performs other job-related duties as assigned.ย 

Requirements

Minimum Education and Experienceย 

  • Master's degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field.
  • 8+ย yearsย relevant experience,ย additionalย education substitutes for experience.ย 

Basic Requirementsย 

  • Demonstrated experience related to human subjects research protections and regulatory compliance including-
    • Reviewing or supporting compliance activities related to human subjects research.
    • Working with Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), research compliance offices, or regulatory oversight organizations.
    • Applying federal regulations governing human subjects research, including 45 CFR 46 (Common Rule).
    • Evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation.
    • Preparing written analyses, regulatory summaries, reports, or compliance correspondence.
    • Managing sensitive information and maintaining detailed records with a high degree of accuracy.
  • Basic knowledge of project management software such as Microsoft Planner, Microsoft Project,ย Asanaย and Smartsheet.ย 
  • Exceptional attention to detail, demonstrated ability to execute instructions, and commitment to quality and compliance.
  • Intermediateย experience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint.ย 

Skills that Set You Apartย 

  • Advanced degree Preferred.
  • Certificates in project management, CIP (Certified IRB Professional), CCRP, CHRC, or related research compliance credential recommended
  • Foundational knowledge of technical writing in areas including process documentation, briefing decks, status reports,ย memosย and other business writing.ย 
  • Basicย knowledgeย of AI tools, including their limitations and risks, and how they can be applied to support project management tasks.ย 
  • Experience in academic medical centers, research institutions, federal agencies, or compliance oversight organizations.
  • Familiarity with electronic compliance or case management systems and document management tools.

About Ripple Effectย 

Ripple Effect isย a woman-owned, 200-person company of communicators, scientists, researchers, and analysts.ย Established in 2003, andย named asย one of the "Best and Brightest Companies to Work For" in 2024 and 2025 by the NABR,ย Ripple Effect has earned acclaim for delivering unparalleled consulting services and top-tier talent across federal, private, and non-profit sectors.ย 

Benefits

At Ripple Effect, we reward our employees for their contributions to our mission. Our comprehensive total rewards package includesย competitive pay, exceptional benefits, and a range of programs that support your work/life balance and personalized preferences.ย ย 

Learn more about our benefits and culture here.ย