The Clinical Data Manager will design and develop case report forms and manage study databases using REDCap or CTDB. They are responsible for data cleaning, query management, and the production of data extracts for regulatory and clinical review.
The Senior CRA is responsible for conducting site initiation, interim monitoring, and close-out visits for clinical trials. They must ensure protocol compliance, manage adverse event documentation, and track corrective and preventive actions.
The specialist will prepare and review IND/IDE applications, safety reports, and protocol amendments while managing regulatory correspondence. They will also maintain regulatory files and support FDA meetings and interactions for clinical research programs.
The manager will oversee multi-site clinical trials from start-up through close-out while managing contract deliverables, budgets, and risks. They will also coordinate clinical operations, regulatory functions, and quality assurance while leading multidisciplinary teams.
The Medical Monitor will perform medical assessments of adverse events and monitor safety data trends throughout clinical studies. They will also provide expert consultation on safety reporting to regulatory bodies such as the FDA, IRBs, and DSMBs.
The Executive Secretary coordinates DSMB meetings, manages agendas, and records minutes while tracking action items and recommendations. They serve as the primary communication link between committee members, investigators, and regulatory staff.
The Clinical Research QA Specialist will develop and maintain monitoring SOPs while conducting quality reviews of regulatory files and monitoring reports. They are also responsible for tracking CAPA effectiveness, supporting internal audits, and delivering GCP training to research staff.
The statistician will perform advanced modeling and survey analysis to support NIH-funded clinical research programs. They will also provide statistical consultation to investigators and assist with the preparation of research manuscripts.
The biostatistician will design clinical studies, develop statistical analysis plans, and perform interim and final analyses for regulatory submissions. They will also contribute to protocols, reports, and manuscripts while working within a multidisciplinary team of clinical investigators and program officials.
The specialist will manage, configure, and migrate clinical research applications such as REDCap and CTDB while ensuring secure handling of genomic and clinical data. They will also provide technical support and maintain compliance with federal information security and regulatory standards.
