Overview
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
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.
Join our team and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love:- Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
- Health Benefits beginning on date of hire
- PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
- Short and Long-Term Disability, Life Insurance, and AD&D
- We celebrate our differences, which enriches our culture!
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.
We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here:
https://www.dol.gov/agencies/whd/postersLabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to
https://www.labconnect.com/If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email
talent@labconnect.com or call +1 (423) 722-3155.