Clinical Trial Operations, Senior Clinical Trial Associate / Clinical Trial Associate

Anavex Life Sciences Corp. is seeking talented and highly motivated Clinical Trial Associates (CTA). This role will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct, and close-out. The successful candidate will be a hands-on clinical trial associate capable of performing quality control of clinical trial documents, assisting with study start-up, conduct and close-out of study activities. This individual will have accountability for managing the collection, review, completeness, and quality of the assigned Trial Master File (TMF).Key Responsibilities

• Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation.
• Set up and maintain study-specific paper and electronic TMFs.
• Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices.
• Track and report CRO's ability to maintain TMF health metrics on an ongoing basis.
• Process essential documents and ensure they are correctly filed in the appropriate TMF.
• Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed.
• Participate in GxP audits and related clinical operations compliance and inspection readiness activities.
• Prepare and track study documents (e.g., contracts, budgets, IRB documentation).
• Assist with information gathering, literature searches, and creation of presentations, as needed.
• Maintain and oversee tasks performed by CRO related to databases / spreadsheets, as necessary, to facilitate tracking / documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.)
• Administer user access and change control within Anavex's electronic systems.
• Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems.
• Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards.
• Assist with vendor management and associated logistics, as assigned.
• Contribute to the creation of presentations, as needed for project, departmental, sponsor, and / or business development presentations.
• Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies.
• Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel)
• Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual.
• Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management.
• Organize and / or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF.
• Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist in creating and implementing departmental SOPs and procedures.The position will be filled at a level commensurate with experience.Requirements
• BS / BA in Life Sciences or equivalent
• 3 years of experience in similar positions in Biotech, Pharmaceutical, or clinical research organization environment
• Extensive experience managing paper and electronic TMF, including set-up, maintenance, QC / QR, and query management.
• Familiar with the DIA reference model
• Knowledge of ICH / GCP and applicable regulations
• Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence the decision-making of managers, and working partners (local and global)
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining a high attention to detail and responding to rapidly changing priorities and aggressive deadlines
• Proficient in MS Office (Word, Excel, Project), Adobe, and ISI Toolbox
• Strong critical thinking, organizational and time-management skills
• Ability and willingness to travel (up to 10% of the time) Learn More