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 with a minimum of 4 years of industry- relevant project, laboratory and management experience required. (May also consider less experience with an M.S. degree or more with a two year degree)
Industry experience with bioanalytical platforms and methodology in support of clinical bioanalytical testing
Demonstrated project and timeline management skills
Good planning and organizational skills with attention to detail
Effective oral and written communication skills with experience in 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
Work Hours/Travel:
100% remote with the ability to travel to the client site approximately 1-2 times per year, on the west coast
Ability to work Monday - Friday, Pacific Coast Hours, with occasional meetings later in the day