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Pierre Tomas - Program Coordinator Resume Simple
To obtain a position in a professional environment where I can utilize my skills and experience to contribute to the success of the company. I am a self-motivated, dependable, and a team player.
leads, budgets, staffing, service, leadership, healthcare, clinical research, research, implementation, clinical
monitoring, training, correspondence, fda, safety, reporting
Leads and directs the development of the project management Plan, including the creation of a comprehensive and effective service manual, and the annual budget.
Project Manager for the implementation of clinical research projects and the development of a new and innovative approaches for the healthcare team.
Oversees the recruiting, onboarding, and orientation of new staff and clinical operations coordinators. Works with research team to ensure that all study related activities are being followed.
Oversee the day-to-day operations of the clinical research coordinators, including the recruiting, onboarding, and development of the trial.
Assist in the planning, execution, and management of clinical trial budgets and staffing. Manage and monitor the work of the clinical research coordinators.
Team leader, leadership and Executive Director. Served as a resource for the staff. Provided support to the department heads.
Regulatory Affairs Specialist
Ennis High School
Reviewed and approved all regulatory documents for submission to the safety monitoring Committee, including the reporting of adverse events, protocol deviations, and amendments.
Ensured that all regulatory documentation, IRB, and IND correspondence are completed and filed in accordance with applicable regulations and guidelines.
Managed the submission of regulatory documents for FDA approval and approval. Reviewed and approved all regulatory submissions for submission to the FDA.
Provided training to new hires on the use of the device. Developed and maintained the study protocol. Created and implemented the standard operating procedures.
Prepares and maintains regulatory documents for submission to the FDA. Prepare and submit regulatory documents to the FDA. Manage the submissions of the study.