Scientific Project Coordinator

Summary:

LabConnect has an immediate opening within FSP Solutions for a Scientific Project Coordinator. This person 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.

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, Required Knowledge and Skills:

B.S., Life Sciences or related field. Master's Degree and/or 2 year degrees 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) Demonstrated project and timeline management skills Proactive mindset/self starter Solid organizational skills with attention to detail and ability to develop and follow process Strong oral and written communication skills with experience in both strong team collaboration and technical writing Experience working with vendors/service providers 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

Work Hours/Travel:

100% remote with the ability to travel to the client site up to approximately 1•2 times per year, on the west coast Occassional meetings later in the day may be necessary to accommodate west coast hours