Laboratory Specialist at PSI CRO

King of Prussia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Jul, 26

Salary

0.0

Posted On

21 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical laboratory support, Clinical research, Laboratory strategy, Quality control, Quality assurance, Data management, Vendor coordination, Risk management, Training, Monitoring visits, Sample management, Communication, Presentation skills, Organizational skills, Microsoft Office

Industry

Pharmaceutical Manufacturing

Description

Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them. Job Description 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.

Responsibilities

The Laboratory Specialist manages all laboratory-related activities within clinical studies, including strategy development, vendor coordination, and quality control. They also provide support to study teams, perform laboratory assessments, and ensure compliance with study protocols.