Seeking a position in the medical field where I can utilize my skills and experience to benefit the company. I am a highly motivated individual with a strong work ethic, and the ability to work well with others.
Assisted in the development and implementation of clinical research Associate training and reporting, including the creation of study related documents, and management of the budget.
Served as the project Manager for the clinical trial team, responsible for the preparation of SOPs, and monitoring of the study files, including the audit of the TMF, and ensuring compliance with all applicable regulations.
Provided support to the project team in the development and implementation of the database for the management of the client.
Participated in the development and implementation of departmental policies and procedures, including the procurement of supplies and equipment, and patient/physician training.
Performed audits of study files and ensured that all the clinical trial management processes are maintained and documented. Managed the day-to-day operations of the project.
Developed and implemented a new study management system, including scheduling, tracking, and distribution of data. Created and maintained project-specific templates and tools.
Lead Clinical Research Associate
Performed clinical monitoring of investigational sites, including: Site selection, initiation, interim, close-out, and closeout visits, audit preparation, reconciliation, budget reconciliation, and purchasing of study supplies.
Managed the site operations, including regulatory document audits, study close-out visits, TMF reconciliation, and SOP development.
Performed site management activities such as file maintenance, regulatory document review, and study close-out visits. Prepared and submitted training documents for clinical trial sites.
Assisted with the development of study documents such as recruitment, protocol, informed consent, subject enrollment, and subject compliance.
Reviewed and approved site visit reports, including but not limited to, source documents, case report forms, study supplies, and other study materials as required by the trial management.
Assisted in the development of study documents including but not limited to, site visit reports, protocol amendments, investigator brochures, study manuals, SOPs, monitoring plans, and other documents.