A Clinical Research Associate (CRA) is a professional who plays a crucial role in the field of clinical research. Their primary responsibility is to ensure that clinical trials are conducted in compliance with regulatory guidelines, protocols, and good clinical practice (GCP) standards. Here are some of the key tasks and responsibilities of a Clinical Research Associate:
Study Start-up: CRAs contribute to the initiation of clinical trials by assisting with site selection, conducting pre-study visits, and ensuring that investigators and study sites are adequately prepared to conduct the research.
Site Monitoring: CRAs conduct regular site visits to monitor the progress of clinical trials. They verify that the trial is being conducted in accordance with the approved protocol, applicable regulations, and GCP guidelines. This involves reviewing and verifying source documents, ensuring proper documentation and record-keeping, and assessing the adherence to study procedures and regulatory requirements.
Data Collection and Quality Control: CRAs review and validate the accuracy, completeness, and consistency of clinical data collected during the trial. They ensure that data is appropriately entered into electronic data capture (EDC) systems and resolve any data discrepancies or inconsistencies.
Participant Safety and Rights: CRAs are responsible for ensuring the safety and welfare of trial participants. They verify that informed consent procedures are followed, adverse events are reported and managed appropriately, and that participants' rights and well-being are protected throughout the study.
Regulatory Compliance: CRAs work closely with regulatory authorities and ethics committees to ensure that all regulatory submissions, including ethics committee approvals and informed consent forms, are accurate and up to date. They also assist in preparing and reviewing study-related documentation, such as study protocols, case report forms, and study reports.
Collaboration and Communication: CRAs collaborate with various stakeholders involved in clinical trials, including investigators, study coordinators, study sponsors, and contract research organizations (CROs). They provide guidance, support, and training to site staff, and maintain effective communication to address any issues or concerns that arise during the trial.
Overall, the role of a Clinical Research Associate is to ensure the integrity, quality, and compliance of clinical trials, thereby contributing to the generation of reliable and scientifically sound data for the evaluation of new medical treatments or interventions.
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.