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

Guidehouse

Clinical Protocol Coordinator

Bethesda, MD · On-site

$130K - $216K/yr

... analyses. * Coordinate recruitment, scheduling, travel, and admission of research participants with clinical staff. * Communicate with IRB personnel and NIH Clinical Center staff regarding protocol ...

Prism Vision Group

Clinical Research Assistant

Fairfax, VA · On-site

$46K - $96K/yr

... analysis of clinical research data. The Clinical Research Assistant will develop knowledge of the ... Responsible for submissions and reports to the IRB; maintains documentation of IRB communications ...

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$32K

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How much do irb analyst jobs pay per year?

As of Aug 17, 2026, the average yearly pay for irb analyst in Silver Spring, MD is $75,735.00, according to ZipRecruiter salary data. Most workers in this role earn between $54,300.00 and $89,900.00 per year, depending on experience, location, and employer.

What is an IRB analyst?

An IRB (Institutional Review Board) Analyst is responsible for reviewing research proposals to ensure they comply with ethical guidelines and regulatory requirements for human subjects' protection. They assess study protocols, verify informed consent procedures, and ensure adherence to federal and institutional policies. IRB Analysts collaborate with researchers to address compliance issues and provide guidance on ethical research practices. Their role is critical in safeguarding participants' rights and welfare while facilitating ethical research.

What are the key skills and qualifications needed to thrive as an IRB analyst?

To thrive as an IRB Analyst, you need a strong background in research ethics, regulatory compliance, and an understanding of human subjects research, often supported by a relevant bachelor's or master's degree. Familiarity with electronic protocol management systems, federal regulations (such as the Common Rule), and certifications like CIP (Certified IRB Professional) are highly valued. Strong attention to detail, analytical thinking, and effective communication skills set outstanding IRB Analysts apart. These qualities are crucial to ensure thorough, ethical review of research protocols and strict adherence to regulatory standards, protecting the rights and welfare of research participants.

What are some common challenges faced by IRB analysts in their daily work?

IRB Analysts frequently navigate complex regulatory requirements while reviewing a diverse range of research protocols, which can present challenges in interpreting guidelines and ensuring full compliance. They must balance efficiency with thoroughness, often working under tight deadlines to support both researchers and institutional standards. Staying current with evolving ethical standards and federal regulations is essential, as is effectively communicating decisions to investigators who may have varying levels of experience. Despite these challenges, the IRB Analyst role is rewarding for those who value ethical oversight and enjoy collaborative, detail-oriented work.

What do you need to be an IRB analyst?

To become an IRB analyst, candidates typically need a bachelor's degree in a related field such as healthcare, research, or ethics, along with experience in research compliance or regulatory environments. Knowledge of federal regulations like the Common Rule and Good Clinical Practice (GCP) is essential, and certifications such as the Certified IRB Professional (CIP) can enhance qualifications. Strong attention to detail, analytical skills, and the ability to review research protocols are also important for the role.

What does an IRB analyst do?

An IRB analyst reviews research protocols to ensure they comply with ethical standards and regulatory requirements set by Institutional Review Boards. They evaluate study procedures, consent forms, and risk assessments, often using specialized software, to protect research participants and maintain compliance. IRB analysts typically have a background in research ethics, healthcare, or related fields and work closely with researchers and regulatory bodies.

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Infographic showing various Irb Analyst job openings in Silver Spring, MD as of August 2026, with employment types broken down into 100% Full Time. Highlights an 50% In-person, and 50% Remote job distribution, with an average salary of $75,735 per year, or $36.4 per hour.

Clinical Protocol Coordinator

Guidehouse

Bethesda, MD • On-site

$130K - $216K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 11 days ago

Guidehouse rating

7.7

Company rating: 7.7 out of 10

Based on 27 frontline employees who took The Breakroom Quiz

42nd of 72 rated business consultants

Job description

Job Family:
Clinical Trial Operations
Travel Required:
None
Clearance Required:
Ability to Obtain Public Trust
What You Will Do:
We are looking for a Clinical Protocol Coordinator to support the operational objectives of the National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD). This position is a full-time position located in Bethesda, MD, with telework eligibility.
  • Work with auditing units, nursing staff, and medical records personnel to support audits, manage audit activities, and collate audit responses.
  • Conduct quality assurance activities and prepare for regulatory audits conducted by FDA, NIH, pharmaceutical sponsors, and other stakeholders.
  • Provide technical support to researchers and clinic staff, including protocol coordination, patient scheduling, registration activities, and resolution of study-related inquiries.
  • Coordinate with IRB administrators to collect, review, maintain, and submit regulatory documentation through the NIH Protocol Tracking and Management System.
  • Independently provide support services to satisfy the overall operational objectives of NCI/DCTD.
  • Prepare standard operating procedures (SOPs) related to audits and clinical research activities.
  • Attend multicenter site calls and prepare detailed meeting notes and communication summaries.
  • Respond to data and regulatory queries from Theradex and prepare written responses in collaboration with nursing staff and data managers.
  • Assist with the preparation and maintenance of regulatory documents required for protocol approvals by FDA, CTEP, IRB, OPRR, and drug sponsors.
  • Update and maintain regulatory binders and ensure the accuracy of study and regulatory records.
  • Assist researchers with protocol development, review, and assembly of clinical trial documentation.
  • Assist in the development of internal research proposals, abstracts, poster presentations, and manuscript drafts.
  • Support the creation of protocol schemas, patient calendars, teaching aids, informed consent documents, and other ethics- and regulatory-related materials.
  • Develop and maintain study-related SOPs and operational procedures.
  • Collect, organize, and maintain study documentation, including investigator qualifications, trial logs, safety reports, annual reports, and correspondence.
  • Write, edit, and maintain study protocols, amendments, reports, and associated regulatory submissions.
  • Prepare and submit study safety reports, annual reports, amendments, and regulatory correspondence.
  • Maintain data files across multiple software systems and communication platforms.
  • Perform data entry, data cleanup, database queries, descriptive statistics, and basic univariate analyses.
  • Coordinate recruitment, scheduling, travel, and admission of research participants with clinical staff.
  • Communicate with IRB personnel and NIH Clinical Center staff regarding protocol approvals and regulatory actions.
  • Incumbent capture, no other candidates were considered due to incumbent candidate identified. They meet the labor category requirements provided by the customer.

What You Will Need:
  • Master's degree
  • Minimum of TEN (10) years of related experience supporting clinical research, clinical trials, protocol coordination, or regulatory compliance activities.
  • Experience supporting clinical trials, clinical research studies, or protocol-driven research environments.
  • Experience preparing, maintaining, and submitting regulatory documentation.
  • Knowledge of quality assurance processes and regulatory audit preparation.
  • Experience working with IRBs, FDA regulatory requirements, and clinical research compliance processes.
  • Ability to anticipate research staff needs and develop alternative processes to support operational objectives.
  • Ability to adapt, create, and utilize tools to analyze and evaluate projects and programs.
  • Proficiency with Microsoft Office Suite.
  • Must be able to obtain and maintain a Federal or DoD "public trust"; candidates must receive approved adjudication prior to onboarding with Guidehouse. Candidates with an active public trust or suitability are preferred.

What Would Be Nice To Have:
  • Familiarity with Clinical Trial Management Systems (CTMS).
  • Proficiency using Electronic Medical Record (EMR) systems.
  • Strong analytical, organizational, and time management skills.
  • Strong written and verbal communication skills.
  • Ability to work independently and collaboratively in a multidisciplinary research environment.
  • Working knowledge of Electronic Data Capture (EDC) systems.
  • Background in clinical trials quality assurance and monitoring.
  • Prior support for NIH, NCI, DCTD, or other federal clinical research programs.
  • Ability to perform descriptive statistical analyses and manage study databases.
  • Demonstrated ability to coordinate multicenter clinical research activities.

The annual salary range for this position is $130,000.00-$216,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
What We Offer:
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Benefits include:
  • Medical, Rx, Dental & Vision Insurance
  • Personal and Family Sick Time & Company Paid Holidays
  • Parental Leave
  • 401(k) Retirement Plan
  • Group Term Life and Travel Assistance
  • Voluntary Life and AD&D Insurance
  • Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
  • Transit and Parking Commuter Benefits
  • Short-Term & Long-Term Disability
  • Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
  • Employee Referral Program
  • Corporate Sponsored Events & Community Outreach
  • Care.com annual membership
  • Employee Assistance Program
  • Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
  • Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
Guidehouse is an Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or guidehouse@myworkday.com. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.
If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse's Ethics Hotline. If you want to check the validity of correspondence you have received, please contact recruiting@guidehouse.com. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant's dealings with unauthorized third parties.
Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

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