What are the responsibilities and job description for the Clinical Trial Specialist (Remote) position at Tandym?
A leading organization is currently seeking a skilled Clinical Trial Specialist for a Remote contract opportunity. This role is pivotal in ensuring the successful execution of clinical trials from start-up through closeout.Responsibilities:Actively involved in the performance of study feasibility assessmentsDevelop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms)Manage the collection, review and approval of regulatory documents from clinical sitesCoordinate investigational product release activities across clinical sitesManage and track study specific paymentsCreate study-specific site budgetsInitiate, maintain and reconcile the Trial Master FileAssist in the preparation of Investigator and Study Coordinator MeetingsSet-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programsCoordinate communication of tracking information within the study team and to the clinical sitesDevelop and review Standard Operating ProceduresPerform other duties, as neededQualifications:Bachelor's DegreePrevious experience in Clinical Trial Coordination and/or Site ManagementUnderstanding of Study Phases and general knowledge of how they apply to Clinical DevelopmentWorking knowledge of ICH Good Clinical Practice guidelinesExperience using computer applications including spreadsheets, email, word-processing software and web-based systems
Salary : $37 - $50