Project Specialist
New
W
WEP ClinicalClinical Research
Remote, USFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 1-3 years
- Required Skills
- Project ManagementGCPSharePointMicrosoft Office
Requirements
- Bachelor’s degree (Health or science field preferred).
- 1-3 years of experience in project management or clinical research.
- Proficiency in Microsoft Office.
- Strong organizational skills and attention to detail.
- Effective verbal and written communication skills.
- Ability to handle confidential information with discretion.
- Ability to remain in a stationary position for extended periods as part of daily activities.
Responsibilities
- Assist with the development and execution of Expanded Access Programs (EAPs).
- Work with the project management team to ensure projects are completed in accordance with client expectations.
- Coordinate and dispatch shipments of investigational products with the supply chain team according to SOPs.
- Support the project and finance teams with filing vendor invoices for EAPs.
- Maintain the sponsor and site contact list and communicate with sites for enrollment.
- Organize and maintain shared program-level documents in OneDrive or SharePoint.
- Review project documentation from investigational sites to ensure compliance with FDA/GCP/ICH requirements.
- Prepare and submit Investigational Product Review Forms (IPRFs) to the regulatory team.
- Maintain study files and electronic trial master files (eTMF).
- Enter and maintain program, site, and patient-level data in the CTMS.
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