Project Specialist

Join Our Team at WEP ClinicalAre 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 ObjectivesAs 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.The Ideal CandidateTeam PlayerAdaptableDetail OrientedProblem SolverWhat You'll DoAssist 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).What You'll NeedBachelor's degree (In a health or science field preferred)1-3 years' experience in project management or clinical researchEffective verbal and written communication skillsComputer literacy and proficiency in Microsoft OfficeAbility to handle confidential information with complete discretionStrong organizational skills and attention to detailWhat We OfferMedical, dental, and vision insurance, FSA, HSAVoluntary short-term and long-term disability insuranceVoluntary life insurance401K safe harbor plan and company matchPaid vacation, holiday, and sick timePaid maternity & paternity leaveWhat Sets Us ApartWEP 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 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.We're Committed to Our TeamWEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.We're Committed to DEIAt 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 IncludeAccess ProgramsClinical Trial ServicesPatient Site SolutionsClinical Trial SupplyMarket Access and CommercializationWEP 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, color, 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.