Scientific Project Coordinator

The Project Coordinator within FSP will be responsible for providing operational oversight and support for outsourced analytical testing in ADA and PK bioanalysis. Support will include monitoring timelines, managing documentation and contracts, maintaining tracking logs, working with external vendor partners, facilitating communications, and participating in all aspects of a study life cycle from initiation to closure.

This is a fully remote role.

Essential Duties and Responsibilities

• Manage analytical method support documentation including dosing documents, reagent qualifications, reagent expiry extensions, and bioanalytical reports.
• Manage study timelines and monitor scheduling and conduct of bioanalytical testing to ensure alignment with data transfer deliverable requirements.
• Assist with monitoring outsourced bioanalytical method performance and identifying analytical trends.
• Communicate project updates and issues to cross functional teams including scientific project managers, internal scientists, CRO staff and operational teams.
• Manage and lead recurring cross-functional meeting series.
• Assist in facilitating contracts with external suppliers.
• Support shipping and reagent requests.
• Maintain trackers related to issues and program-specific information.
• Support sample disposition requests.
• Contribute to the maintenance of external collaboration sites.
• Manage logistics for new clinical study initiation.
• Participate in and/or lead operational process improvements.

Education and Experience

• B.S. in Life Sciences or related field. Master's degree and/or associate’s degree may be considered with different levels of work experience.
• 4 years of industry-relevant project and/or laboratory management experience required.
• 1-3 years of Large Molecule PK/ADA/NAb Bioanalytical bench experience preferred (validation experience in the laboratory is a plus).
• Experience working with vendors/service providers preferred.

Skills and Ability

• Ability to work Monday - Friday, Pacific Coast Hours, with occasional meetings later in the day.
• Demonstrated project and timeline management skills.
• Solid organizational skills with attention to detail and ability to develop and follow processes.
• Strong oral and written communication skills with experience in both strong team collaboration and technical writing.
• Understanding of clinical trial processes.
• Working knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or Clinical Laboratory Improvement Amendments (CLIA).
• Strong computer literacy, including word processing, SharePoint, presentation, and spreadsheet applications.
• Ability to work effectively in a cross-functional team matrix environment.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.

Supervisory Responsibilities: None

Physical Demands: 

While performing the duties of this job, the occupant is regularly required to:

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.