RESEARCHPOINT GLOBAL Oncology Clinical Research Associate in AUSTIN, Texas

Oncology Clinical Research Associate - Future Projects WuXi AppTec US-TX-Austin Job ID 2018-4642 Overview Job Summary: The Clinical Research Associate II performs and coordinates aspects of the field-based and office-based monitoring and data quality control functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), and ResearchPoint Global SOPs. This can be a work from home position and requires approximately 50-75% travel. Responsibilities Essential Job Functions: Provides operational support for Clinical Operations Performs field-based and in-house monitoring and site management tasks to assure conformance to current regulatory, ResearchPoint Global, and sponsor requirements Performs data quality control functions including, but not limited to, query management and data audit functions Participates in team and sponsor meetings and training programs, as required Produces and maintains documentation of activities and findings as required by ResearchPoint Global and sponsor Fiscal management of trip costs, positive feedback from site staff, low data error rates, complete and timely site monitoring, expense, and time sheet reporting Position requires employee be aware of budget constraints for travel time, in-house and time at site and to manage to those constraints and to alert supervisor and project manager if they cannot be effectively managed May provide informal guidance to more junior employees/contractors on project-specific tasks Receives direct supervision from Project Managers, Clinical Managers or above Receives daily project supervision from project managers and data managers Must show ability to present solutions to issues; must show ability to apply previous lessons to future project work Is expected to apply decisions from previous discussions to new situations and seek confirmation only Must show ability to review regulatory documents in advance of Quality Assurance review with high level of accuracy and make decisions on the quality of the documents and take appropriate action Must make effective decisions on managing tasks within time constraints so that deadlines are not missed Expected to require supervision on issues that can have substantial impact on clinical, data quality, or regulatory issues Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required Normally receives minimal instructions on routine work and detailed instructions on new assignments Works under close supervision from supervisor or senior personnel Ability to work in a team environment and independently as required Qualifications Job Requirements Experience / Education: Expected to have a minimum of 3 years related clinical research experience and a minimum of three months co-monitoring or co-auditing in the field or equivalent Bachelor's degree or HS diploma with commensurate experience Preference given to those with CCRC, CCRA, CCRP certifications Oncology / Critical Care experience preferred Knowledge / Skills / Abilities: Proficient skills with Microsoft Office Suite applications Must have strong attention to detail and demonstrate understanding of the critical nature of ResearchPoint Global documentation Must have ability to initiate steps according to established processes without intervention Must have ability to interact with internal and external customers and sites professionally, using clear diction Must exhibit concise technical writing skills with minimal grammatical or logical errors Ability to organize workload and handle multiple priorities Must be able to solve problems independently when required and must be able to anticipate risks to the project within the scope of the position and to propose solutions to supervisor Must have positive, professional demeanor with all interacti