Clinical Trial Specialist

Overview

• Provide logistical support for clinical trial programs, ensuring compliance with SOPs and regulations.
• Collaborate with cross-functional teams to manage site start-up and close-out activities.
• Develop and review essential study and clinical site documents.
• Coordinate investigational product release and regulatory document management.
• Track study-specific payments and create site budgets.
• Maintain and reconcile the Trial Master File and tracking systems.
• Support study metrics reporting and communication within the study team.
• Participate in initiatives and working groups as a subject matter expert.
• Mentor Clinical Trial Associates and assist in training Clinical Research Associates.

Key Responsibilities & Duties

• Conduct study feasibility assessments and manage ancillary vendor relationships.
• Assist in the preparation of Investigator and Study Coordinator Meetings.
• Perform site initiation, monitoring, and close-out visits as needed.
• Review site visit reports under the direction of the Clinical Program Manager.
• Develop and review Standard Operating Procedures for clinical trials.
• Coordinate communication of tracking information within the study team and clinical sites.
• Negotiate aspects of study-specific site budgets and manage payments.
• Support study-specific training and mentoring for team members.
• Ensure compliance with ICH Good Clinical Practice guidelines and applicable regulations.

Job Requirements

• Bachelor of Science degree in a relevant field is required.
• Minimum of 2 years of experience in clinical trial coordination or site management.
• Preferred 4 years of experience in clinical trial operations.
• Understanding of study phases and their application to clinical development.
• Proficiency in computer applications, including spreadsheets, email, and web-based systems.
• Effective verbal and written communication skills.
• Ability to manage multiple tasks and deadlines efficiently.
• Self-motivated and capable of analyzing moderate scope and complexity problems.
• Willingness to travel up to 10% as required.