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

Howard

Research Assistant

Washington, DC

$50K - $60K/yr

Research Assistant will report to Dr. Sergei Nekhai. She/he will be guided by a postdoctoral fellow ... Help to renew IBC, IACUC and IRB protocols. CORE COMPETENCIES: * Self-motivated, cooperative, and ...

Howard University

Research Assistant

Washington, DC · On-site

$50K - $60K/yr

Research Assistant will report to Dr. Sergei Nekhai. She/he will be guided by a postdoctoral fellow ... Help to renew IBC, IACUC and IRB protocols. CORE COMPETENCIES: * Self-motivated, cooperative, and ...

Medix

Clinical Research Coordinator

Washington, DC · On-site

$45 - $60/hr

Manage timelines for annual IRB renewals and closures. * Assist the Principal Investigator (PI) with site management and follow-up calls. Qualifications * Proven experience managing clinical trial ...

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Irb Assistant information

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 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 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 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.
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Infographic showing various Irb Assistant job openings in Silver Spring, MD as of August 2026, with employment types broken down into 86% Full Time, and 14% Part Time. Highlights an 71% In-person, and 29% Remote job distribution.

Clinical Research Program Specialist (Oncology)

Johns Hopkins University

Washington, DC • On-site

$48K - $84K/yr

Full-time

Re-posted 13 days ago

Johns Hopkins University rating

8.0

Company rating: 8.0 out of 10

Based on 71 frontline employees who took The Breakroom Quiz

186th of 617 rated colleges and universities

Job description

Under limited supervision of the Sr. Clinical Research Program Manager, we are seeking a Clinical Research Regulatory Specialist who will be responsible for managing regulatory maintenance of clinical trials, assisting development of investigator-initiated studies, maintaining sponsor relationships, and facilitating compliance and continuing education trainings for the specific Oncology Clinical Research Program. Regulatory maintenance activities include amendment applications to the IRB and other regulatory agencies, and internal quality control of regulatory document management. This position requires a high level of knowledge, oversight, and organization, and will serve as a central resource for faculty conducting clinical research. Responsibilities will also include orient and train research staff in the program, assist budget development and oversee overall study coordination, and support general operations of the program.
Specific Duties & Responsibilities
  • Work closely with Program Manager and PI's to evaluate study status and complete regulatory requirements, including protocol submissions to IRB and relevant ancillary groups for smooth and timely implementation of protocol amendments.
  • Assist with revision of investigator-initiated studies; assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
  • Work closely with PI's and sponsors to complete all study amendment submissions to the IRB, Cancer Center Cores (such as Sibley TSCRC Lab and IDS Pharmacy), and other required regulatory documents.
  • Track each protocol through Oncology and IRB approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
  • For National Cancer Institute trials where Sibley is the lead site, work closely with the project manager and PI to submit the signature institution worksheet for approval, schedule study start-up meeting, maintain communication to ensure high quality of data, timely submission of data, and adherence to guidelines.
  • Conduct internal quality assurance measures, including periodic monitoring and training sessions, to ensure all clinical research faculty and staff within the program are up-to-date with regulatory guidelines, standard operating procedures, and certification requirements.
  • Maintain a continued high level of expertise in institutional databases including Epic, OnCore, eReg, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
  • Assist Program Manager with program operations and staff orientation and training - providing suggestions for improved procedures, creating checklists and program-related standard operating procedures.
  • Participate as requested in Cancer Center initiatives such quality-improvement workgroups and committee meetings.
  • Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies.
  • Ensure that Cancer Center policies, standard operating procedures, and guidelines related to the conduct of clinical trials are followed.

Minimum Qualifications
  • Bachelor's Degree in a related field.
  • Five years of related experience in clinical research in an academic.
  • Minimum of 2 years' experience in clinical trial and/or clinical research in a patient setting required.
  • Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications
  • Certification as a Clinical Research Professional is preferred.

Classified Title: Clinical Research Regulatory Specialist
Job Posting Title (Working Title): Clinical Research Program Specialist (Oncology)
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $48,000 - $84,100 Annually ($65,400 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri / 8a -4:30p
FLSA Status: Exempt
Location: Hybrid/District of Columbia
Department name: SOM Onc Sibley
Personnel area: School of Medicine

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About Johns Hopkins University

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Gilman believed that teaching and research go hand in hand—that success in one depends on success in the other—and that a modern university must do both well. He also believed that sharing our knowledge and discoveries would help make the world a better place. In 145 years, we haven’t strayed from that vision. This is still a destination for excellent, ambitious scholars and a world leader in teaching and research. Distinguished professors mentor students in the arts and music, humanities, social and natural sciences, engineering, international studies, education, business, and the health professions. Those same faculty members, along with their colleagues at the university’s Applied Physics Laboratory, have made us the nation’s leader in federal research and development funding every year since 1979. That’s a fitting distinction for America’s first research university, a place that has revolutionized higher education in the U.S. and continues to bring knowledge and discoveries to the world.

Industry

Colleges, universities, and professional schools

Company size

10,000+ Employees

Headquarters location

Baltimore, MD, US

Year founded

1876

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