Clinical Trial Associate - CEDENT

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.
 

• 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.
   

• 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.