Job Description

Job Description

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 assessments
• Develop 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 sites
• Coordinate investigational product release activities across clinical sites
• Manage and track study specific payments
• Create study-specific site budgets
• Initiate, maintain and reconcile the Trial Master File
• Assist in the preparation of Investigator and Study Coordinator Meetings
• Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs
• Coordinate communication of tracking information within the study team and to the clinical sites
• Develop and review Standard Operating Procedures
• Perform other duties, as needed

• Bachelor's Degree
• Previous experience in Clinical Trial Coordination and/or Site Management
• Understanding of Study Phases and general knowledge of how they apply to Clinical Development
• Working knowledge of ICH Good Clinical Practice guidelines
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
  

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