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 cross-functional 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.
- 2-4 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 fast-paced environment.
- Effective in cross-functional team settings.
Department : Direct Clients
This is a full-time position.
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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. Document Management: Manage trial documents within the Veeva Vault Trial Master File (TMF), including ...
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