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:
- 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