Job Description

The Project Coordinator will be responsible for providing oversight and management of assay development, validation, study monitoring, and troubleshooting of outsourced flow cytometric and biomarker methods, He/she will provide project management and technical support to teams conducting training, data review, and data representation. The Project Coordinator must have the ability to effectively monitor the performance of CROs and service providers. The incumbent will also be responsible for operational documentation including SOPs, validation protocols and reports, transfer protocols and reports, and management reports.
This position is fully remote. The standard hours are 11:00 AM to 8:00 PM EST, including a one-hour break.
Responsibilities:

• Provide project management oversight and subject matter expertise in flow cytometry and biomarker assays, method development, validation, and technical transfer to ensure scientific integrity and adherence to the protocol/plan/contracts and applicable regulations.
• Interact with CROs and effectively communicate updates, reports, and recommendations to management teams.
• Provide analytical project oversight by performing data review and collation, evaluate assay quality, monitor performance, and manage timelines.
• Provide technical support to troubleshoot specific issues that impact the project.
• Manage Supplier performance and relationships with attention toward opportunities to cut costs, alleviate risks, and drive continuous improvement.
• Recommend and implement new processes and procedures to standardize, simplify, and enhance quality and compliance of the department's operations.

Education and Qualifications:

• Industry expertise with development and qualification of flow cytometric methods including. immunophenotyping and receptor occupancy assays
• Experience with Computational Biology automated data reduction scripts

Required Skills

• Strong understanding of clinical biomarker assay development troubleshooting and data review
• 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

Language Ability
Must possess the ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. The ability to write reports, business correspondence, and procedure manuals is needed. The ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public is also necessary.
Math Ability
The ability to apply advanced concepts is required.
Reasoning Ability
Handles detailed, complex concepts and problems, balances multiple tasks simultaneously, and makes rapid decisions regarding administrative and executive issues. Must display excellent analytical, reasoning and problem-solving skills
Computer Skills
To perform this job successfully, an individual should have advanced knowledge of Microsoft Office applications, word processing software, spreadsheet software, accounting software and database software.
Supervisory Responsibilities
This position does not have supervisory responsibilities.
Work Environment
The noise level in the work environment is usually moderate.
Physical Demands
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus. While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to reach with hands and arms.

Skills Required