Sr Associate - Project Coordinator

Project Management

Responsibilities

Project and Timeline Management

Manages material management and shipping activities for assigned studies; PK and Immunogenicity testing

Tracks supplier timelines, deliverables, and study milestones, identifying risks and issues early

Documents issues, actions, and decisions in accordance with established processes

Supplier and Stakeholder Coordination

Serves as primary point of contact for assigned suppliers

Communicates updates to suppliers, BAPS, and R&S regarding timelines, issues, and study status

Coordinates responses to requests for additional testing or information

Documentation and Reporting

Drafts and maintains study documentation, trackers, and reports

Reviews and submits study reports for internal review

Supports budget tracking and loss reporting activities

Compliance and Process Adherence

Ensures coordination activities comply with GCP, GLP, and CLIA requirements

Supports audit readiness through accurate documentation and timely issue resolution

Tools and Systems

Utilizes SharePoint, spreadsheets, and presentation tools to manage trackers, reports, and communications

Qualifications

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.

Minimum Requirements

Bachelor's degree & 2 years of related experience

AND

Excellent written and verbal communication skills

Preferred Requirements

Experience using electronic document management systems and principles

Outstanding attention to detail, including the ability to verify data/information, proofread, and reformat documents

Strong team player working across multiple sites and R&D functions

Proficient in Microsoft office and online collaboration tools

Sharp learning agility, problem solving, and multi-tasking skills

Reliable contributor with the ability to work independently

Experience in biotechnology or other healthcare environment

Competencies

Understanding and application of principles, concepts, theories and standards of professional field

Specialized knowledge within the informed consent field, biobank operations, and a basic knowledge about laboratory information management systems

Drafting and interpreting clinical protocol and ICF language

Knowledge of related regulatory/industry considerations and compliance issues