Clinical Research Associate jobs in Kentucky

​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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

​Kentucky has a presence in the life sciences field. While Kentucky is often associated with industries like agriculture and bourbon production, the state also has a growing life sciences sector. Several universities, research institutions, and biotech companies in Kentucky are actively engaged in various areas of life sciences research and development. These include:

1. University of Kentucky: The University of Kentucky has a strong life sciences program, with research and academic departments dedicated to fields such as biology, biochemistry, molecular biology, genetics, neuroscience, and more. The university also houses the Markey Cancer Center, which focuses on cancer research and treatment.

2. University of Louisville: The University of Louisville is another major institution with a strong emphasis on life sciences. It has departments and research centers dedicated to biomedical sciences, cardiovascular research, cancer research, neurology, and other related fields.

3. Kentucky Bioprocessing (KBP): KBP, a subsidiary of the global biotech company Alltech, is located in Lexington, Kentucky. It specializes in the production of pharmaceuticals and vaccines using plant-based technologies.

4. Kentucky BioProcessing (KBP): KBP, a subsidiary of the global biotech company Alltech, is located in Owensboro, Kentucky. It specializes in the production of pharmaceuticals and vaccines using plant-based technologies.

5. Kentucky Science Center: Located in Louisville, the Kentucky Science Center is a science museum that offers educational programs and exhibits related to various scientific disciplines, including life sciences.

6. The Coldstream Research Campus: Situated in Lexington, the Coldstream Research Campus is a 735-acre business park focused on research and development. It is home to various companies and organizations engaged in life sciences research, including biotechnology and pharmaceutical companies.

These are just a few examples of the life sciences presence in Kentucky. The state is actively working to promote and grow its life sciences sector by fostering collaboration between academia, industry, and government entities.