Project Specialist

2 months ago

Morrisville, United States WEP Clinical Full time
Job DescriptionJob DescriptionSalary:

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical and play a vital role in the successful management of Expanded Access Programs (EAP), Open-Label Extension Studies (OLE), and Post Approval Named Patient Programs (PA-NPP). We challenge our team to bring thought-provoking ideas to the table and to help define and drive solutions for clients and patients. Join us in our mission to improve patient outcomes and make a difference in the field of clinical research.


Role Objectives:


As a Project Specialist at WEP Clinical, you will be responsible for the operational and administrative support of the setup, implementation, and management of EAPs, PA-NPPs, and/or OLE studies. Your responsibilities will include maintaining, organizing, and reviewing electronic trial master files, clinical trial management systems, and supporting the team in exceeding client expectations.


The Ideal Candidate:


  • Team Player
  • Adaptable
  • Detail Oriented


Principal Duties and Responsibilities:


  • Assist with the development and execution of clinical research programs, including expanded access and post approval named patient programs.
  • Work with the project management team to ensure projects are completed in accordance with client expectations.
  • Work with the supply chain team to coordinate and dispatch shipments of investigational products according to the WEP Clinical SOP’s.
  • Support the project team and finance team with filing vendor invoices for Expanded Access Programs
  • Maintain the sponsor and site contact list.
  • Communicate with sites for EAP enrolment and maintenance as needed.
  • Organize and maintain shared program-level documents within internal OneDrive or SharePoint.
  • Assist with project documentation collection and review from investigational sites, ensuring they meet FDA/GCP/ICH requirements.
  • Prepare Investigational Product Review Forms (IPRFs) and submit to WEP Clinical Regulatory team.
  • Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master File (eTMF).
  • Enter and maintain program, site, and patient-level data into the EAP Clinical Trial Management System (CTMS).


Qualifications:


  • Bachelor’s degree (In a health or science field preferred)
  • 1-2 years’ experience in project management or clinical research
  • Effective verbal and written communication skills
  • Computer literacy and proficiency in Microsoft Office
  • Ability to handle confidential information with complete discretion
  • Strong organizational skills and attention to detail


What We Offer:


  • Medical, dental, and vision insurance
  • Short-term disability insurance
  • Life insurance
  • Voluntary Long-term disability insurance
  • 401K safe harbor plan and company match
  • Paid vacation, holiday, sick, and volunteer time
  • Paid maternity & paternity leave
  • Personal Development Allowance


What sets us apart:


WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over a decade of experience distributing products worldwide to treat unmet patient needs.


We're Committed to Our Team:


WEP has many initiatives in place to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, all that we do to support our employees.



We're Committed to DEI:


At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.



Our services include:


Expanded Access Programs (EAPs)

Open Label Extension Studies (OLE)

Named Patient Programs (NPPs)

Clinical Trial Supplies (Comparator & Ancillaries)

Wren Nursing (Clinical Trial Home Nursing & Clinical Education)

Hospital Supply of Unlicensed Medicines


WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.


WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

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