McKenzie Kocheran

Responsible for monitoring clinical trial sites to ensure studies are conducted in accordance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. Collaborate closely with investigators and site staff, provide training on study procedures, track study progress, resolve issues, and prepare detailed monitoring reports. Assist with regulatory submissions, maintain study documentation, and help ensure trials meet quality, ethical, and compliance standards.

Key duties include overseeing participant safety and data integrity, performing routine site visits, verifying source documents, and ensuring timely collection and reporting of study data.

Developed and implemented the Clinical Research Quality and Regulatory Specialist role for the Investigational Drug Services Pharmacy, establishing comprehensive compliance framework, streamlined workflows, and quality oversight processes that strengthened regulatory readiness and operational excellence across clinical trials. Monitored investigational pharmacies for multi-center studies in which Nationwide Children’s Hospital served as the coordinating site, ensuring protocol adherence, regulatory compliance, and consistent study drug management across all locations.

Served as the primary liaison between study sponsors and the research team on all regulatory matters, guiding the IRB submission and approval process to ensure timely and compliant study start-up. Managed the creation and ongoing maintenance of essential regulatory documents and the study administrative binder, ensuring accuracy, organization, and readiness for audit or review. Additionally, Coordinated and facilitated onsite visits, providing tours, managing sponsor and CRO requests, and supporting monitoring activities to maintain strong communication, transparency, and operational efficiency throughout the trial.

Reviewed clinical trial protocols to develop clear and accurate consent and assent documents, prepare complete IRB submissions, draft and submit protocol amendments, respond to contingencies, and maintain essential regulatory documents on behalf of the Principal Investigator. Oversaw the preparation, submission, and ongoing management of all documentation and processes related to clinical research activities, ensuring compliance and audit readiness. Ensured accuracy and alignment across IRB materials, regulatory files, study documents, and the grants system, supporting seamless study operations and adherence to institutional and federal requirements.

Supported the development of research protocols, recruitment strategies, and study-related materials to ensure clarity, feasibility, and alignment with study objectives. Managed all operational aspects of pulmonary research studies, including conducting informed consent and assent, coordinating recruitment and scheduling, maintaining IRB documentation, collaborating with multidisciplinary teams, administering interviews, overseeing data collection, performing data analysis, and ensuring accurate data management throughout the study lifecycle. Worked closely with Principal Investigators, study staff, and ancillary departments to drive study progress, maintain regulatory compliance, and ensure the overall success of each clinical research project.

Assessed client needs and developed individualized treatment and service plans designed to support mental health stabilization and improve community functioning. I coordinated care by connecting clients with appropriate services—including therapy, housing assistance, medical care, and other community resources—to ensure comprehensive and continuous support. Conducted risk assessments and provided crisis intervention when necessary, prioritizing client safety and stabilization while facilitating timely access to essential care.