ClinicalTrialAssociate

_**Job Description:**_ **Responsibilities** * Help maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out * Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders * Coordinate study meetings, materials and agendas; recording and disseminating decisions and actions * Responsible for internal meeting agendas/minutes as applicable * Responsible for updating, maintaining and quality control of the eTMF, SharePoint site and shared drive * Responsible for study laboratory sample tracking and vendor management support * Track new vendors and purchase orders in financial system * Coordinate version control of clinical documents, prioritize multiple tasks and/or projects * Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages * Support Clinical Operations team with specific projects * Effectively communicate with study team members and work closely to address challenges **Minimum Qualifications** * BS/BA degree or equivalent and at least 1-3 years experience in clinical operations in Sponsor company * Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures * Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations * Experience with eTMF; ability to directly apply essential document knowledge to file documents * Effective communication, organizational and interpersonal/team skills * Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project and SharePoint preferred. * Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines * Participate in inter-departmental workgroups to create or enh