The Clinical Trial Associate supports the clinical operations project team to ensure the smooth execution of clinical trial processes in compliance with regulatory guidelines and ICH / GCP standards.
This role involves managing trial documents coordinating project activities and assisting with compliance and audit preparation.
Key Responsibilities :
Document Management : Manage trial documents within the Veeva Vault Trial Master File (TMF) including user access training and quality checks for completeness and compliance.
Quality Control : Perform quality checks on TMF documents and resolve discrepancies ensuring team adherence to document requirements.
Project Coordination : Coordinate crossfunctional project meetings with the Clinical Project Manager (CPM) prepare agendas and minutes and track action items.
Study Materials : Assist in creating study materials including documents presentations and reports.
Tracking and Metrics : Support the CPM in maintaining tools for tracking metrics such as site activation patient enrollment and site contacts.
Essential Documents : Review and collect essential documents for compliance with SOPs protocols and regulations.
Investigational Medicinal Product (IMP) Packet : Create and review IMP release packets and conduct background checks for potential new sites.
Audit and Inspection Preparation : Assist study teams and sites in audit and inspection preparation.
Process Improvement : Participate in workgroups to enhance internal processes and procedures.
Training and Vendor Management : Assist in training CRO teams investigators and study members; serve as the point of contact for vendors and oversee selected vendor activities.
Clintrials.gov Management : Update Clintrials.gov as required.
Administrative Support : Provide general administrative support for clinical trial execution.
Requirements :
Bachelor s degree or nursing degree required; scientific or healthcare field preferred.
24 years of experience in clinical research or a related field such as at a clinical site CRO sponsor or clinical trial vendor.
Good Clinical Practice (GCP) training and knowledge of clinical research guidelines.
Experience with Veeva TMF and proficiency in MS Word Excel PowerPoint and Outlook.
Strong attention to detail ability to prioritize tasks and meet deadlines.
Professional communication skills for interactions across all levels of the organization.
Ability to manage multiple competing tasks in a fastpaced environment.
Effective in crossfunctional team settings.
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