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Clinical Project Coordinator

2 months ago

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Job Overview

Salary: Competitive

Are you seeking a rewarding opportunity in the field of clinical research? At WEP Clinical, we are dedicated to enhancing patient outcomes through effective management of Expanded Access Programs (EAP), Open-Label Extension Studies (OLE), and Post Approval Named Patient Programs (PA-NPP). We encourage our professionals to contribute innovative ideas and help shape solutions for our clients and the patients we serve.

Key Responsibilities:

As a Clinical Project Coordinator at WEP Clinical, your role will encompass operational and administrative support for the establishment, execution, and oversight of EAPs, PA-NPPs, and/or OLE studies. Your duties will include:

  • Maintaining and organizing electronic trial master files and clinical trial management systems.
  • Collaborating with the project management team to ensure timely project completion in line with client expectations.
  • Coordinating with the supply chain team for the shipment of investigational products as per WEP Clinical's standard operating procedures.
  • Assisting the project and finance teams with vendor invoice processing for Expanded Access Programs.
  • Updating and managing the sponsor and site contact lists.
  • Facilitating communication with sites regarding EAP enrollment and ongoing maintenance.
  • Organizing and managing shared program-level documents within internal systems.
  • Supporting the collection and review of project documentation from investigational sites to ensure compliance with FDA/GCP/ICH standards.
  • Preparing and submitting Investigational Product Review Forms (IPRFs) to the Regulatory team.
  • Assisting in the preparation of study files based on project requirements, including the upkeep of electronic document storage systems.
  • Entering and maintaining program, site, and patient-level data in the EAP Clinical Trial Management System (CTMS).

Qualifications:

  • Bachelor's degree in a health or science-related field is preferred.
  • 1-2 years of experience in project management or clinical research.
  • Strong verbal and written communication skills.
  • Proficiency in Microsoft Office and computer literacy.
  • Ability to manage confidential information with discretion.
  • Excellent organizational skills and attention to detail.

Benefits:

  • Comprehensive medical, dental, and vision insurance.
  • Short-term and long-term disability insurance options.
  • Life insurance coverage.
  • 401K plan with company matching.
  • Generous paid time off including vacation, holidays, and sick leave.
  • Paid parental leave.
  • Personal Development Allowance for professional growth.

Our Commitment:

WEP Clinical is dedicated to partnering with sponsors to provide patients and healthcare providers with early access to medications when traditional treatment options are unavailable. With over a decade of experience, we specialize in distributing products globally to address unmet patient needs.

Team and Diversity:

We prioritize wellness, growth, and team relationships, fostering an inclusive environment that values diversity, equity, and inclusion. Our commitment to DEI ensures that all employees have opportunities for personal and professional development, recognizing and embracing their unique identities.

WEP Clinical is an equal-opportunity employer and maintains a smoke-free, drug-free, and alcohol-free workplace.