Clarity R

Clinical Research Project Manager

Jun 2025 - Present • 11 mos

Manage and support clinical research studies within an academic medical center, with a primary focus on IRB submissions, protocol development, consent form design, and regulatory compliance. Extensive experience preparing and revising IRB applications, including initial submissions, modifications, and responses to reviewer feedback. Work involves identifying approval-risk issues, improving clarity and structure, and aligning study documents with regulatory expectations to facilitate smoother review and approval processes. Regularly collaborate with investigators, trainees, and research teams across multiple study types to refine protocols, consent forms, and supporting documents. Provide detailed feedback and targeted revisions to strengthen study design, improve readability, and ensure submissions are clear and well-organized for IRB review. Experience spans both qualitative and quantitative research, with familiarity in study design, data collection methods, and documentation requirements across academic and clinical settings. Strong focus on efficiency and structure, with a workflow designed to deliver high-quality, actionable feedback with minimal back-and-forth. This approach supports timely submissions while maintaining attention to detail and compliance standards. Background in reviewing and optimizing research proposals in addition to IRB-related documents, helping ensure that study aims, methods, and overall structure are clearly communicated and aligned with reviewer expectations.

Lead Clinical Research Coordinator

Apr 2022 - May 2025 • 3 yrs 1 mo

Led coordination of a large portfolio of clinical research studies, including multisite and sponsor initiated trials, with responsibility spanning study startup through closeout. Managed IRB submissions, regulatory compliance, and study documentation across the full study lifecycle. Prepared and submitted protocols, consent forms, amendments, and continuing reviews in accordance with institutional and federal requirements. Supported study startup activities and ensured proper closeout procedures and documentation. Managed day to day study operations, including participant recruitment, informed consent, and data collection. Developed and refined consent forms and study materials to improve clarity, accuracy, and compliance. Served as a key liaison between investigators, regulatory teams, sponsors, and institutional stakeholders to ensure timely study progress and regulatory adherence. Supported investigators in addressing IRB feedback and revisions to facilitate approval and ongoing compliance. Maintained regulatory binders and ensured accurate documentation throughout the study lifecycle. Assisted in training and guiding research staff on study procedures, regulatory standards, and best practices.