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.
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.