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The Clinical Research Associate will partner with Clinical Research Leadership in delivering commitments and supporting the day-to-day operations for the Clinical Research organization within Vaccine Research & Development (VRD), through the handling of multiple priorities, decision making, and information flow, to ensure deadlines and obligations are met. S/He will contribute to the success of crucial Vaccine Clinical Research and Development (VCRD) initiatives, providing operational support and management and coordination on a varied portfolio of clinical activities. S/He will also effectively manage and execute select project responsibilities related to key VCRD remits and VCRD Leadership Team-related events, end-to-end.
The major responsibilities will include but are not limited to:
• Manage and coordinate the Vaccine Clinical Review Committee (VCRC) reviews and meetings for the development of clinical study outlines, clinical study protocols, and risk management documents. This includes identifying the process to follow and reviewers to invite based on document type and clinical program, identifying meeting dates, setting up meetings, distributing materials, managing timelines, collecting and archiving meeting minutes, and maintaining distribution lists.
• Work closely with Vaccine Clinical Research leadership to identify challenges and revise VCRC processes as necessary for the execution of efficient VCRC meetings.
• Coordinate with Clinical Compliance colleagues to produce and maintain monthly organizational charts for audit and inspection purposes.
• Coordinate with Clinical Scientist Group Leads to produce, maintain, and distribute a monthly list of Vaccine Clinical Research studies (Study Master List).
• Produce monthly PTMF metrics reports for completion status of documents within the remit of Clinical and Statistics groups. Collaborate with Clinical Compliance Head for required follow-up actions.
• Coordinate VCRD compilation, review, and distribution of Investigator Packages at end of each clinical study. Ensure receipt of packages at all clinical sites.
• Assist with compilation of the supplemental tables and figures section of clinical study reports.
• Lead coordination of CSR appendices review, working in collaboration with Medical Writer, Clinical Scientist Communication Leads, and appendices owners.
• Support the VRD and Pearl River vision and goals through close partnership with VRD and site leadership to effectively implement operational plans and priorities.
• Take initiative to bring forward ideas for process improvements and more efficient operations.
• Ensure accuracy of work and use judgment to determine work methods in different situations.
• Demonstrate collaboration and communication skills in a team environment, share knowledge, influence best-practices and coordinate workflow.
• Associate's Degree or Bachelor's Degree with a minimum of 2 years of experience preferred in Business Operations, Project Management, or Clinical Research.
• 1+ years of experience in the Biopharmaceutical industry preferred.
• Proven ability to manage day-to-day planning and operational activities.
• Experienced in communicating and interacting with senior stakeholders.
• Experienced in managing multiple, competing tasks simultaneously; executing complex strategies.
• Demonstrated ability to work collaboratively with diverse teams, across multiple lines; ability to manage a cross functional team of colleagues.
• Demonstrated understanding of systems, structures, and implementing efficient processes.
• Demonstrate resourcefulness with proven ability to anticipate needs, prioritize responsibilities, manage multiple priorities with tight timelines, and take initiative with a minimal amount of supervision.
• Strong project management skills with demonstrated attention to detail.
• Possess a high energy level, sense of urgency, creativity, decisiveness, ability to work hard and well under pressure.
• Demonstrated strong self-starter, independent, proactive, and self-motivated.
• Ability to exhibit sound judgment in handling confidential information.
• Ability to work well both in team environment as well as operate independently with minimal supervision.
• Possess excellent communication skills with an ability to respond with professionalism in verbal and written communications with all levels of the organization.
• Proficiency in MS Word, Excel, PowerPoint, and Outlook are essential.
• Know and model our client Values/Core Competencies.
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