CRA who conducts monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards as defined in the clinical trial. Perform management of study site activities working under a PM to ensure the collection of accurate clinical data within given timelines.
• Manages all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity
• Scientifically monitors clinical studies, which includes but is not limited to the review of case report forms (CRFs) and source documentation to ensure adherence to the protocol and consistency and scientific validity of the data
• Provides full support including technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials
• Assists project team with project-related activities, e.g. feasibility, enrollment, recruitment and status reports
• Prepares for, conducts and reports on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
• May be involved in the preparation of documentation for submission to IRB/IECs and CAs as well as coordination of submission with appropriate site staff and /or Project Manager/CRA Manager
May assume responsibility for multiple studies. Position is home based. The activities should be performed in close cooperation with the project manager and/or VP Clinical.
• Excellent working knowledge of clinical research processes, Good Clinical Practices, federal regulations and applicable local laws pertaining to clinical research investigations
• Understands and complies with client’s procedures and instructions
• Strong knowledge base of medical terminology
• Fluent written and verbal English language skills
• Good communication and documentation skills. Is able to communicate with people of different education and organizational level.
• Attention to detail and a methodical approach to work
• Ability to organize and take initiative
• Ability to handle and prioritize multiple assignments in a fast-paced work environment
• Ability to identify issues proactively, identify resolutions and follow through to completion in an independent manner
• Ability to work independently with minimal oversight as well as actively contribute to a project team