Sr Associate- Project Coordinator

<h2><b>Career Category</b></h2>Project Management<h2></h2><h2><b>Job Description</b></h2><p><b><u>Responsibilities</u></b></p><p><b>Project and Timeline Management</b></p><p>·Manages material management and shipping activities for assigned studies; PK and Immunogenicity testing</p><p>·Tracks supplier timelines, deliverables, and study milestones, identifying risks and issues early</p><p>·Documents issues, actions, and decisions in accordance with established processes</p><p><b>Supplier and Stakeholder Coordination</b></p><p>·Serves as primary point of contact for assigned suppliers</p><p>·Communicates updates to suppliers, BAPS, and R&amp;S regarding timelines, issues, and study status</p><p>·Coordinates responses to requests for additional testing or information</p><p><b>Documentation and Reporting</b></p><p>·Drafts and maintains study documentation, trackers, and reports</p><p>·Reviews and submits study reports for internal review</p><p>·Supports budget tracking and loss reporting activities</p><p><b>Compliance and Process Adherence</b></p><p>·Ensures coordination activities comply with GCP, GLP, and CLIA requirements</p><p>·Supports audit readiness through accurate documentation and timely issue resolution</p><p>Tools and Systems</p><p>·Utilizes SharePoint, spreadsheets, and presentation tools to manage trackers, reports, and communications</p><p></p><p><u>Qualifications</u></p><p><i>  The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.</i></p><p></p><p>Minimum Requirements</p><p></p><p>•Bachelor’s degree &amp; 2 years of related experience</p><p>AND</p><p>•Excellent written and verbal communication skills</p><p></p><p><b><u>Preferred Requirements</u></b></p><p>•Experience using electronic document management systems and principles</p><p>•Outstanding attention to detail, including the ability to verify data/information, proofread, and reformat documents</p><p>•Strong team player working across multiple sites and R&amp;D functions</p><p>•Proficient in Microsoft office and online collaboration tools</p><p>•Sharp learning agility, problem solving, and multi-tasking skills</p><p>•Reliable contributor with the ability to work independently</p><p>•Experience in biotechnology or other healthcare environment</p><p></p><p><b><u>Competencies</u></b></p><p>•Understanding and application of principles, concepts, theories and standards of professional field</p><p>•Specialized knowledge within the informed consent field, biobank operations, and a basic knowledge about laboratory information management systems</p><p>•Drafting and interpreting clinical protocol and ICF language</p><p>•Knowledge of related regulatory/industry considerations and compliance issues</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.