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.
Here is an overview of Cincinnati and its potential as a life sciences location:
Home to several large healthcare systems including Cincinnati Children's Hospital Medical Center, TriHealth, Mercy Health, and UC Health. This provides clinical research and talent pipelines.
The University of Cincinnati and Cincinnati State Technical and Community College offer relevant life sciences degree programs.
Multiple business parks and incubators exist, like Hamilton Landing and BioStart, aimed at attracting biotech companies.
Several large companies have presences, including Procter & Gamble, Kroger, and Ethicon Endo-Surgery. Opportunities for partnerships.
Part of a tri-state region with Northern Kentucky and Indianapolis, providing access to a large labor pool.
Cost of living and real estate are lower compared to major biotech hubs.
However, lacks the density of other emerging biotech hubs like Miami or San Diego. Early stages of development.
Ohio provides some tax incentives but less VC funding compared to coastal states.
Cincinnati offers affordable real estate, clinical assets, and a skilled workforce that could support growth of its life sciences sector.