Job Description

This is a hybrid role, requiring partial office-based work from our King of Prussia, PA office on a weekly basis.

In this position you will be involved in some or all of the following tasks at any given time:

1. Study related activities (Laboratory Support). Manages all laboratory related activities within a clinical study under supervision, including:

• Reviews study documents
• Provides expert advice to PSI and Sponsor study teams
• Contributes to the development of diagnostic strategies, including the development and review of assay validation plans and reports
• Documents and drives the Laboratory Strategy
• Presents laboratory strategy at kick-off meetings
• Supports the selection of central and regional laboratories for studies
• Performs qualification of off-site / on-site laboratories for a study
• Coordinates the contracting of central / regional / off-site laboratories
• Performs central / regional / off-site laboratory set up
• Contributes to Risk Management process
• Provides information to PSI Data Management (DM) to aid eCRF design
• Delivers training to the study team and/or clinical sites in laboratory related procedures
• Performs initiation and monitoring visits to laboratories as required
• Coordinates routine calls with central laboratories
• Attends study progress calls with the Sponsor
• Provides support / consultancy to Sponsor / PSI team for all laboratory related issues
• Investigates issues with laboratories / couriers / sites
• Coordinates the transfer of samples between laboratories
• Assists DM in on-going data reconciliation
• Coordinates any changes to the laboratory strategy
• Performs close out of central / regional off-site laboratories

2. Quality Control & Quality Assurance:

• Develops and/or implements operational (project specific and laboratory specific) quality control documents
• Participates in system audits and follows up on audit findings related to laboratories that provide testing for the assigned projects

3. Business Development:

• May be required to assist with consultancy in business development tasks

Qualifications

• University or college degree in Life Sciences required
  • An MD degree PhD degree is a plus
• At least 2 years experience working in a clinical laboratory setting or practical microbiology/ mycology/ molecular biology / biochemistry
• Prior clinical research industry experience is a plus
• Strong communication and presentation skills
• Attention to detail and organizational skills are critical
• Ability to work in a team setting as well as independently as needed
• Proficient in using Microsoft Office tools

Additional Information

All your information will be kept confidential according to EEO guidelines.