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.
Sunrise, Florida has a presence in the life sciences industry. While it may not be as prominent as some other cities known for their life sciences sectors, such as Boston or San Francisco, Sunrise has a few notable institutions and companies in this field. Here are a few examples:
American Anatomical Corporation: This company, located in Sunrise, specializes in anatomical and biological materials for medical education, research, and training.
CoreRx: CoreRx is a contract development and manufacturing organization (CDMO) based in Sunrise. They offer pharmaceutical development services, including formulation development, analytical testing, and clinical trial manufacturing.
Thermogenesis Group: Thermogenesis Group, a subsidiary of Cesca Therapeutics, is headquartered in Sunrise. The company focuses on developing and commercializing automated systems for processing and storing cellular therapies and stem cells.
Sawgrass Technology Park: Located in Sunrise, the Sawgrass Technology Park is a business park that hosts several companies across various industries, including the life sciences sector. It provides a conducive environment for research and development activities.
It's important to note that this information is accurate up to my knowledge cutoff in September 2021. It's recommended to verify the current state of the life sciences industry in Sunrise, Florida, by referring to local business directories, industry reports, or contacting local economic development organizations for the most up-to-date information.