Clinical Trial Assistant

Employment Type

: Full-Time

Industry

: Miscellaneous



POSITION SUMMARYThe Clinical Trial Assistant works closely with cross functional teams in planning, start-up, maintenance & closeout of study activities in Clinical Operations and Medical Affairs related study activities in compliance with the protocol, Good Clinical Practice (GCP), and government regulations. The position provides logistical support for clinical trial programs with minimal supervision following standard operating procedures as established by the Clinical Operations department.Responsibilities* Assists with in-house reconciliation of IWRS queries to ensure compliance with case report forms (EDC), protocol, pharmacy manual and standard operating procedures (SOPs).* Recommends sites for oversight visits based on pre-specified criteria (i.e., repeat major deviations, failure to perform drug accountability appropriately, etc.)* Manages the collection, review, and approval of regulatory and essential documents from clinical sites* Manages the submission of protocols, amendments, subject facing documents to Central IRB for review and approval for U.S. sites and follows up on or coordinates responses to IRB questions and queries* Interfaces with site coordinators, field clinical staff, CROs and other company representatives* Is actively involved in the performance of study feasibility assessments* Coordinates investigational product release activities across clinical sites* Responsible for ordering study binders, inserts and assembly for Zogenix conducted studies* Responsible for ordering and shipping specified supplies for clinical studies and maintains inventories* Assists in the preparation of Investigator and Study Coordinator Meetings* Maintains tracking systems and reports study metrics to support the clinical trial programs* Responsible for study-specific training of Clinical Research Assistants* Responsible for assigning site numbers* Participates in and presents status updates in project team meetings* User Acceptance Testing for various clinical systems* Other duties as requiredQualifications* Bachelor's degree required preferably in a health sciences field* Minimum 2 years experience in a clinical role in the life science industry with understanding of clinical roles and terminology* Highly proficient in software applications such as Word, Excel and PowerPoint. Database skills preferred* Good written and verbal communication skills* Ability to multitask* Strong organizational skills with attention to detail* A problem solver with good analytical and research skills

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