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.
Job Summary
The Project Coordinator is responsible for collaborating with the Project Managers, internal LabConnect departments, sites, sponsors, with daily ongoing clinical trial study projects, requests, and specifications:
Essential Duties and Responsibilities
Ensures appropriate communication channels are maintained with Sponsors and Contract Research Organizations as the Secondary Project Contact
Promptly responds to interactions with Project Managers, internal LabConnect departments, sites, & sponsors.
Updates all on-going project status to Project Managers as needed and monthly to direct manager.
Provides support for investigation and resolutions for Quarantine samples as needed.
Interfaces with, but not limited to, the following: Project Management, Sponsors, investigator sites, reference laboratories, Investigator Support Services, Clinical Trial Materials, Information Technology, Data Management personnel, and Executive Leadership Team.
Updates and maintains Study specific Site Lists containing vital site information that is utilized by multiple departments.
Verifies that Investigator’s Site information is accurate and up to date in all applicable databases.
Generates Lab Report Access Forms for anyone seeking access to Lab Reports
Receives, verifies, and processes all returned Lab Report Access Forms, including but not limited to: ensuring forms are filled out properly, filed on SharePoint in study specific folder, and submission to the Quality Control Process
Provides response on supply requests, corrections, patient reports, and other inquiries and concerns. Requests project management assistance, when necessary.
Documents meeting minutes & maintains the Project Dashboard Tracker spreadsheet and allows for edits from the Project Manager to be provided and distributed to attendees within 24-48 hours.
Addresses escalated 4th day site queries & Double Data Entry quires through communication with the investigator site, sponsor, & PM contacts.
Manages Study Closure Protocol notes as needed in applicable database.
Completes and Submits Work Order requests to our Clinical Trial Materials department as requested.
Provides study-specific (non-client facing) management reports to clients on a reoccurring basis.
Facilitates distribution of study documents, such as the distribution of site memos to sites and sponsors, at the request of Project Managers.
Manages Portal User Account Access in applicable system, including but not limited to creating, adjusting, and deactivating user’s access.
Supports Study Set Up Managers with study set up tasks that include but are not limited to:
Creation of SalesForce Projects, Updating SalesForce tasks/milestones/project health/Opportunity Amendments
Creation of study specific email addresses.
Creation of study in Replicon
Exhibits an understanding of each protocol from a Project Coordinator’s perspective.
Serves as a reference point for clinical investigators, handling questions, concerns, and complaints.
Performs other related duties and tasks as necessary or as assigned.
Education and Experience
Required: We’re looking for someone who shines in customer service, stays organized, communicates well, juggles multiple tasks with ease, and connects naturally with others.
Preferred (but not required):
Bachelor’s or associate degree
University program certificate
2–4 years of relevant lab experience
Experience or training in the clinical trial industry
Or any combination of the above!
Skills and Ability
Language Ability
Must possess the ability to read, analyze, and interpret general business periodicals, professional journals, or technical procedures. Must be able to draft clear and effective business communications. The ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public is necessary.
Math Ability
Basic math proficiency required, no advanced math knowledge necessary.
Reasoning Ability
The ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists is necessary. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form is preferred.
Computer Skills
Office applications, word processing software, spreadsheet software, and database software.
To perform this job successfully, an individual should have advanced knowledge of Microsoft.
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