CRA Corner

Clinical Research Associates (CRAs) are essential to any successful clinical trial. They are responsible for monitoring and managing Phase I-III clinical trials to assess the study’s progress in assigned trial sites (either on-site or remotely). They ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, company, sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local regulatory requirements.

 

At PiVOT, we understand the importance of CRAs in clinical trial management. We have developed a comprehensive program to ensure our CRAs are well-trained and experienced. By providing our CRAs with the necessary training and experience, we can ensure that our clinical trials are conducted according to the highest safety, accuracy, and efficiency standards.

Primary Duties & Responsibilities

Knowledge of a CRA

Skills of a CRA

Excellent analytical, organizing, and problem-solving skills;

Excellent computer skills including computer statistical, technical, and database applications, proficient in Microsoft Office tools, and Google workspace.

Proficient and effective communication skills both oral, written and presentation in English: able to communicate at all levels and functions within a broad and complex clinical research environment in a positive and influential manner.

Good Clinical Practice (GCP) certification

GCP is an essential requirement for any Clinical Research Associate (CRA) involved in clinical trials and clinical research. GCP certification ensures high standards of research conduct, patient safety, and ethical practice, and is an integral part of the clinical research process. With GCP certification, CRAs are better equipped to ensure the quality and integrity of clinical trials and research, and to protect the rights and welfare of participants in the research process. GCP certification provides an assurance to those who are involved in clinical research that the research is being conducted in accordance with the relevant regulations, ethical standards, and best practices.