Clinical Research Associate II

Clinical Research Associate II #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # What you ll do Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports. Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff. Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol. Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s). Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability. Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification. More about you On your first day we ll expect you to have: Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology. Ability to perform all clinical monitoring activities independently. Bachelor s or equivalent degree in biological science, pharmacy or other health related discipline. Strong interpersonal, written, and verbal communication skills within a matrixed team. Experience working in a self-driven capacity, with a sense of urgency and limited oversight. A client-focused approach to work and flexible attitude with respect to assignments/new learning. The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s). An honest and ethical work approach to promote the development of life changing treatments for patients. Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.