Assists in the development of study documents and study preparation prior to the start of a study.Engages with CRCs (Clinical Research Coordinators) and study P.I.s during study preparation to ensuredocuments and procedures are documented in accordance with the protocol, GCP, and company SOPs.Manages the status and required items needed for studies involving the IRB, not limited to studysubmissions, deviation / SAE reporting, and study closeout.Engages with clients (when applicable) during study preparation phase to ensure all necessarydocuments (safety letter, informed consent, etc.) are finalized prior to IRB submission.Assists in the review and/or development of new protocols, assessments, procedures, andtechnologies.Assist with the development and updating of SOPs, WI, and training material related to studypaperwork creation and IRB management.Ensure compliance with regulations.Provides excellent customer service to clients, and maintains positive interaction with peers andsupervisorsAdheres to internal standards, policies, and procedures.