Junior CRA-In House

What you'll be doing: Responsible for management and monitoring TMF. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. Provide internal project specific support for regional CRAS and study sites. Develop rapport with external relationships with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function. Responsible for communicating issues in accordance with the clinical sops. Perform regulatory document preparation, distribution, receipt, review and tracking. Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned projects. Data entry and study report/spreadsheet maintenance. Responsible for project meeting minutes. Invoice and payment tracking.

What your background should be: Minimum 6+ months of professional experience in pharmaceutical related industry preferred. Thorough understanding of ICH/GCP guidelines and regulations as relate to protocol/site management. Knowledge of general clinical research including investigator site issues, important milestones and strategies to ensure timelines are met. Knowledge of the pharmaceutical industry and the pre-clinical, clinical, regulatory and commercial components. A detailed understanding of project planning and management methods. Knowledge of regulatory documents and requirements. Proficient in MS Word, Excel, PowerPoint, Access and publisher. Proactive problem solving skills.

Who is the client company: This is an efficient, metric based clinical research organization (CRO) with a global footprint of operations.; If you are interested in this position, send your resume to apply@kochdavis.com