IntegReview IRB is an independent Institutional Review Board that provides a variety of services to research entities that are engaged in the development of new drugs, medical devices and other types of research (i.e. educational). It is the responsibility of the IRB to ensure the protection and welfare of volunteers involved in research.
IntegReview is a woman-owned business and an equal opportunity employer and does not discriminate against persons because of age, race, color, religion, disability, gender, ethnic, national origin, or veteran status.
JOB SUMMARY/DESCRIPTION: In alignment with government regulated guidelines in regards to the protection of human subjects involved in clinical research [specifically the Code of Federal Regulations, Title 21; Parts 50, 54, 56, 312, 314, 812 and Good Clinical Practices], the purpose of this position is to provide quality assurance (QA) on study-related documents submitted by pharmaceutical, device and biotech companies, Contract Research Organizations (CROs), Principal Investigators, etc. Additionally, to enhance and maintain the quality of services provided to clients.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Detail oriented (required)
Ability to multi-task in fast-paced environment
Accurate typing skills
Excellent written and oral communication skills
Excellent organizational and time management skills
Ability to prioritize and meet timelines
One-two years of administrative experience in a research office specifically in a regulatory or quality assurance/quality control or IRB environment or equivalent. Will consider other industry or related experience.
Previous experience in regulatory document review is preferred.
Working knowledge of interpretation of IRB-related and human subject’s regulations.
Experience working both independently and cooperatively in a fast-paced setting.
Certification or willing to obtain certification is preferred.
Ability to read, analyze and interpret general business and regulatory documents. Ability to write routine reports and correspondence. Ability to speak effectively and respond to questions from staff, managers, clients, etc.
IntegReview IRB provides ethical review for pharma, device, biotech and independent researchers in the U.S., Latin America, and Japan. We are a Woman-owned independent IRB that has been in operation since 1999. Fully accredited AAHRPP.