Clinical Research Associate jobs in Raleigh

​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.

​Raleigh, North Carolina has emerged as a fast-growing hub for the life sciences industry:

• Part of the Research Triangle region along with Durham and Chapel Hill, home to Duke University, UNC Chapel Hill, and NC State - major research universities.

• Numerous biotech companies spawned from university research located in the Triangle, as well as offices for large pharmas like Biogen, Bayer, Merck.

• Raleigh specifically has over 250 life sciences companies with more in nearby Research Triangle Park. Key presence in biopharmaceuticals.

• Home to contract research organizations like IQVIA providing clinical/research services.

• Strong talent pipeline from the universities and presence of companies creates opportunities.

• North Carolina offers tax incentives, grants, and initiatives aimed at biotech growth. The Biotech Center accelerates industry development.

• Lower costs of living and real estate compared to legacy hubs like Boston/San Francisco.

• Still growing and emerging compared to established biotech hubs but has very positive momentum.

Raleigh has become a magnet for biotech in North Carolina, demonstrating fast growth that aligns with the broader Research Triangle's strengths in life sciences research and commercialization.