Project Specialist

Wepclinical; Morrisville (NC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

FSA/HSA available

Life and disability insurance

401K with company match

Paid vacation and holidays

Job summary

WEP Clinical is seeking a Project Specialist to support EAP setup, implementation, and management. You will maintain trial master files, CTMS data, and assist with vendor invoicing while coordinating with project, supply chain, and regulatory teams.

The role requires a Bachelor’s in health/science (preferred), 1–3 years of project management or clinical research experience, and strong communication with proficiency in Microsoft Office.

Qualifications

• Bachelor’s degree in health or science preferred.

Responsibilities

• Provide operational and administrative support for setup, implementation, and management of Expanded Access Programs (EAPs).
• Maintain and review electronic trial master files and CTMS.

Skills

Team Player

Adaptable

Detail Oriented

Problem Solver

Verbal and Written Communication

Microsoft Office

Confidential Information Handling

Organizational Skills

Education

Bachelor’s degree in health or science

Tools

Microsoft Office Suite

Job description

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). 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 Expanded Access Programs (EAPs). Your responsibilities will include maintaining, organizing, and reviewing electronic trial master files, clinical trial management systems, and supporting the team in exceeding client expectations.

• Team Player
• Adaptable
• Detail Oriented
• Problem Solver
• Assist with the development and execution of EAPs.
• 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 EAPs.
• Maintain the sponsor and site contact list.
• Communicate with sites for EAP enrollment 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).
• Bachelor’s degree (In a health or science field preferred)
• 1-3 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
• Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate

Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.

What We Offer

• Medical, dental, and vision insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, sick and volunteer time
• Paid maternity & paternity leave

What Sets Us Apart

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

We're Committed to Our Team

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

How We Work at WEP Clinical

At WEP Clinical, we look for individualswho are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services Include

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization

Data Privacy Notice

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.

Privacy Policy: https://www.wepclinical.com/privacy-policy/

Job Applicant Privacy Notice: https://www.wepclinical.com/privacy-policy/

For Your Safety, Please Note

We will never communicate with you via Microsoft Teams or text message.

We will never ask for your bank account information at any stage of recruitment.

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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