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.
Miramar is a city in Broward County, Florida located between Miami and Fort Lauderdale that has been growing as a hub for life sciences companies. Here are some key factors about Miramar for the life sciences industry:
Home to Scripps Research, a major non-profit biomedical research institute focused on areas like immunotherapy, molecular medicine, medicinal chemistry, and more. This provides a strong anchor for attracting other organizations.
Nearby Nova Southeastern University and its Health Professions Division provides skilled graduates in fields like pharmacy, dentistry, optometry, and physician assistant programs.
Companies like Quest Diagnostics, Humana, and Aetna have established operations in Miramar, taking advantage of the talent pool and proximity to Scripps.
Part of the Florida Research Coast concentrated in Broward County with over 1,300 life science companies and research centers. Allows for cluster benefits.
Miramar has designated a Life Science Park specifically zoned for biotech, pharma, and medical device companies to set up facilities. Incentives offered.
Strong transport links via interstates, rail, and proximity to Miami and Fort Lauderdale international airports. Also near Port Everglades for importer/exporters.
Lower costs of living and real estate compared to other biotech hubs make it attractive for startups and younger workers.
Overall, Miramar provides accessible real estate, talent, research institutes, and transportation infrastructure that make it well-positioned to be part of the growth of biotech in South Florida. Its research anchors and partnerships across the region give it solid foundations.