Laboratory Specialist

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

• Reviews laboratory-related study documents
• Provides laboratory-related advice to PSI and Sponsor study teams
• Contributes to the development of diagnostic strategies
• Presents laboratory strategy at kick-off meetings
• Supports the selection for studies
• Performs assessments of off-site / on-site laboratories for a study
• Coordinates the contracting of laboratory vendors
• Performs set up of laboratory vendors
• Contributes to Risk Management process
• Provides information to PSI Data Management (DM) to aid clinical rial database 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
• Investigates issues with laboratories
• 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 laboratories

2. Quality Control & Quality Assurance:

• Participates in the development and/or implementation of 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

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
• 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 :

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people then PSI is the right choice for you.

Remote Work :

No

Employment Type :

Full-time