Job
Description
As a Sr Associate- Project Coordinator, you will be responsible for project management and coordination of material management and shipping activities for assigned studies including PK and Immunogenicity testing. Your role involves tracking supplier timelines, deliverables, and study milestones while identifying risks and issues early. You will also document issues, actions, and decisions in accordance with established processes. Your key responsibilities will include: - Serving as the primary point of contact for assigned suppliers - Communicating updates to suppliers, BAPS, and R&S regarding timelines, issues, and study status - Coordinating responses to requests for additional testing or information - Drafting and maintaining study documentation, trackers, and reports - Reviewing and submitting study reports for internal review - Supporting budget tracking and loss reporting activities - Ensuring coordination activities comply with GCP, GLP, and CLIA requirements - Supporting audit readiness through accurate documentation and timely issue resolution - Utilizing SharePoint, spreadsheets, and presentation tools to manage trackers, reports, and communications Qualifications required for this position include a Bachelors degree with 2 years of related experience, excellent written and verbal communication skills, experience using electronic document management systems, outstanding attention to detail, proficiency in Microsoft Office and online collaboration tools, strong team player skills, sharp learning agility, problem-solving abilities, and experience in biotechnology or other healthcare environments. Additionally, preferred qualifications include specialized knowledge within the informed consent field, biobank operations, and a basic knowledge of laboratory information management systems. You should also have experience in drafting and interpreting clinical protocol and ICF language, knowledge of related regulatory/industry considerations and compliance issues. This role is at a Senior Level, and you will be expected to apply principles, concepts, theories, and standards of the professional field, demonstrating competencies in various areas related to project coordination and management. As a Sr Associate- Project Coordinator, you will be responsible for project management and coordination of material management and shipping activities for assigned studies including PK and Immunogenicity testing. Your role involves tracking supplier timelines, deliverables, and study milestones while identifying risks and issues early. You will also document issues, actions, and decisions in accordance with established processes. Your key responsibilities will include: - Serving as the primary point of contact for assigned suppliers - Communicating updates to suppliers, BAPS, and R&S regarding timelines, issues, and study status - Coordinating responses to requests for additional testing or information - Drafting and maintaining study documentation, trackers, and reports - Reviewing and submitting study reports for internal review - Supporting budget tracking and loss reporting activities - Ensuring coordination activities comply with GCP, GLP, and CLIA requirements - Supporting audit readiness through accurate documentation and timely issue resolution - Utilizing SharePoint, spreadsheets, and presentation tools to manage trackers, reports, and communications Qualifications required for this position include a Bachelors degree with 2 years of related experience, excellent written and verbal communication skills, experience using electronic document management systems, outstanding attention to detail, proficiency in Microsoft Office and online collaboration tools, strong team player skills, sharp learning agility, problem-solving abilities, and experience in biotechnology or other healthcare environments. Additionally, preferred qualifications include specialized knowledge within the informed consent field, biobank operations, and a basic knowledge of laboratory information management systems. You should also have experience in drafting and interpreting clinical protocol and ICF language, knowledge of related regulatory/industry considerations and compliance issues. This role is at a Senior Level, and you will be expected to apply principles, concepts, theories, and standards of the professional field, demonstrating competencies in various areas related to project coordination and management.
