IRB Document Specialist I

SABAI GLOBAL, a leader in providing Institutional Review Board (IRB) services, works diligently to protect the rights, safety and welfare of human research participants who participate in research studies. We have an opening for an IRB DOCUMENT SPECIALIST I in a fully remote role. In this role, your PRIMARY DUTIES would include:

• Generates and finalizes IRB approved documents, including informed consent forms, participantfacing materials, and IRB determination letters.
• Ensure that documents are handled carefully to maintain document naming conventions, document control, document organization, and document integrity.
• Follows established SOPs and guidelines closely.
• Converts tracked/redlined documents into final format.
• Assists with the preparation of consent forms and other routine study documents. Under supervision, may work on more complicated or unusual study documents.
• Works closely with IRB Analysts to prepare and package documents for release to clients. May help distribute IRB documents and determination letters to study contacts.
• Escalates issues as needed to higherlevel roles (Document Specialist II, Senior Document Specialist, and/or team lead).
• Maintains documents in online portal system. May suggest improvements to the system for process improvements.
• Performs quality control review of approved IRB documents, making sure that documents are free from typos, spacing or formatting issues, or other errors prior to releasing to clients.
• Maintains electronic records related to IRB submissions and study documents.
• Works effectively with team, proactively selects work items to promote workload balance among team members, provides timely updates to workload tracker.

SUCCESSFUL CANIDATES will have:

• High school diploma or general education degree (GED) required, combined with at least 2 years’ experience in office administration processes. Alternately, a bachelor’s degree with proven skills in document editing and organizational skills would be an acceptable substitute for direct work experience.
• Keen attention to detail, ability to multitask, prioritize and remain organized.
• Demonstrated ability to work within a remote team.
• Demonstrated ability to follow standard operating procedures.
• Comfortable with a moderate degree of repetition in work tasks.

PREFERRED QUALIFICATIONS include:

• Direct work experience in IRB, clinical research, or similar setting.
• Familiarity with Federal Regulations (FDA, DHHS) and ICH Guidelines for clinical trials.

Sabai Global is an Equal Opportunity Employer. Candidates needing assistance with the application process, due to differing abilities, should contact [email protected]. About Sabai Global From our initial founding, Sabai has protected the safety, rights and welfare of those who participate in clinical trials and those that conduct the research. We began by providing biosafety services and oversight for institutions, and our uniquely personal approach to deep expertise and white-glove service soon drove expansion into IRB review and consulting. Today, we support sponsors and sites across all phases of research and all therapeutic areas, including biologics, human factors, devices and social behavioral research. We deliver a complete suite of services to our pharmaceutical and institution partners. We’re proud to always remain a people-focused company. Through this principle we serve as a true partner to our clients—thoughtfully and expertly curating the best solutions to meet their needs, throughout the clinical trial process. We are Principled. We are Passionate. We are People-first. If all of this resonates with you, we would like to hear about your story. Apply tot his job Apply To this Job