Clinical Trial Specialist (Remote)

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

Qualifications :