Sample Coordinator - Duesseldorf, Deutschland - LabConnect, LLC

Beschreibung

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 logístical solutions.

The Sample Coordinator is responsible for handling all aspects of sample receipt and accessioning and sample storage.

This role also tracks the shipment of samples from the sample accessioning area, main on-site laboratory, or to third party recipients by courier as necessary.

In addition, responsible for liaising with investigator sites and/or other LabConnect personnel to ensure that the samples and data received are complete, consistent and accurate.

You will manage project activities to our client's specification, ensuring quality deliverables are on time and within budget. Additionally, the Coordinator will work with project management to manage the problems box and resolve all discrepancies. Coordinator will fulfill all destruction requests as delegated by the shipping lead and/or management.

This role will ensure that all work is conducted in accordance with the ICH E6 (R2) Guidance on Good Clinical Practice, for which training will be provided.

Responsibilities:

• Reviews and commits digital forms and manages sample tracking/forecasting per study contract and OSD specifications
• Provides sample tracking services for the company's SampleGISTICSTM Services projects (SGS). The Sampling Coordinator will work closely with other staff within SGS and with the PRM department to provide operational support for SGS projects
• Sample checkin/chainofcustody management
• Coordinate shipping sample specimens to (specialty) labs and sponsors and ordering necessary storage codes inclusive of generating manifests and performing mass status changes
• Works with courier to troubleshoot shipping issues
• Specimen storage at all temperatures, including LN
• Preparing inventory reports, manage/ update site lists and all biorepository housekeeping tasks
• Performs Form Review/Queries and resolve sample discrepancies
• Monitors edit checks and QC forms as necessary and works with ISS/BRS on form/sample issues
• Manages Site/Lab digital pen usage and compliance and escalates digital pen issues to appropriate group
• Provides study updates on all ongoing projects to designated personnel as requested (queries, site issues, sample issues, tracking issues, digital pen installations, shipment tracking information, etc.) and provide immediate response to inquiries and concerns.
• Serves as the secondary project contact with Sponsors and Contract Research Organizations to ensure appropriate communication channels are maintained.
• Performs QC of requested protocol related documents before they are released to the client
• Interfaces with investigator sites, project management, reference laboratories, customer service, shipping, and data management personnel
• Assures all investigators' site information is validated in applicable databases
• Serves as reference point for clinical investigators; exhibiting a thorough understanding of tracking, pens, queries and tracking related concerns and escalate or pass all other inquiries PC

Required skills

• Excellent attention to detail, strong planning and problemsolving skills.
• Excellent organizational and time management skills
• Excellent listening and verbal comprehension skills, including ability to translate client needs to team members. Ability to make wellthoughtout decisions and adapt to changing environments and requirements
• Selfmotivating and ability to work well independently as well as using a collaborative team approach
• Ability to adhere to established timelines, processes and procedures
• Proficient in Microsoft Word, Excel, and database software
• Customer service/client relationship management skills
• Fluent in German and English language, third European language is a plus

Education/Experience
Language Ability
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Fluent in German and English language.
Computer Skills
Physical Demands
The employee must occasionally lift and/or move up to 10 Kg. Specific vision abilitie