A Study Management Associate (SMA) is typically a role within the field of clinical research or pharmaceutical industry. The primary responsibility of a Study Management Associate is to provide support to the study management team in planning, executing, and monitoring clinical trials or research studies. Their tasks may vary depending on the organization and specific study, but generally, their responsibilities include:
Study Planning: SMAs assist in the development and implementation of study protocols, study manuals, and study-specific procedures. They contribute to the design of data collection tools and ensure they comply with regulatory requirements.
Regulatory Compliance: SMAs help ensure that all necessary regulatory documentation and approvals are obtained before the study can commence. They may assist with submitting study protocols and other required documents to regulatory authorities and ethics committees.
Study Execution: During the course of the study, SMAs support the study management team by coordinating various activities. They may assist in site selection and initiation, preparing study-related materials, organizing investigator meetings, and providing training to study site personnel.
Data Management: SMAs play a role in data collection and management. They may assist in setting up electronic data capture systems, monitoring data quality, and resolving data discrepancies. They may also contribute to the development of data management plans.
Study Monitoring: SMAs may participate in monitoring visits to study sites to ensure adherence to the study protocol, regulatory guidelines, and good clinical practices. They may assist in reviewing source documents, verifying data accuracy, and resolving any issues identified during monitoring.
Documentation and Reporting: SMAs help maintain study documentation and ensure it is complete and accurate. They may assist in the preparation of study reports, including interim and final reports, and contribute to study publications or presentations.
Communication and Collaboration: SMAs collaborate with various stakeholders involved in the study, including study sponsors, investigators, study site personnel, and other study team members. They may assist in facilitating communication, organizing meetings, and maintaining effective working relationships.
Study Management Associates provide essential support to ensure the smooth execution of clinical trials or research studies, assisting in various aspects of study planning, execution, data management, and regulatory compliance.
Florence, Kentucky is increasingly becoming a hub for life sciences companies and research organizations in the greater Cincinnati metro area. Here's an overview of the life sciences landscape in Florence:
Part of the Northern Kentucky region, which has seen growth in biosciences over the last decade. The area has sought to attract pharma/biotech companies.
Home to a campus of Cincinnati Children's Hospital Medical Center, a leading pediatric research hospital. This enables clinical trials, medical R&D, and a pipeline of talent.
The Florence area specifically has a cluster of pharmaceutical companies like Meridian Bioscience, APIC Corporation, Ashland Chemical Company focused on drug manufacturing and diagnostic testing.
Strong university presence with the University of Cincinnati and Northern Kentucky University providing skilled graduates for the industry.
Right across the river from Cincinnati which has major companies like P&G, Kroger, and Kao brands which need R&D support and offer partnership opportunities.
Part of the Kentucky Innovation Network and KY Biomedical Innovation Group initiatives to build up life sciences in the state. Access to tax incentives.
Centrally located in the Midwest with good transportation infrastructure via Cincinnati/Northern Kentucky International Airport.
In summary, Florence offers a skilled workforce, research institutions, an existing cluster of pharma companies, and geographic access to partnerships that collectively make it an attractive emerging hub for life sciences in the US.