IRB Document Specialist I

Job Description

REQUIREMENTS

• 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.

RESPONSIBILITIES

• 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.

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