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Site Management Associate I
PSI CRO AG. Serve as the main point of contact between site personnel and CRA involved in the project, helping with query resolution and EDC completion .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial administration, including managing site communications, regulatory submissions, and document management. Proficient in coordinating training and ensuring compliance with local regulations in a dynamic team environment.
Highest-signal resume keywords
Clinical Research ExperienceKnowledge of Local RegulationsProficiency in MS Office ApplicationsExperience as CTA for CROsCommunication and Collaboration Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial AdministrationQuery ResolutionEDC CompletionCTMS ManagementInventory ManagementRegulatory SubmissionsDocument ManagementSite Event TrackingInvestigator Site File PreparationProject Training Coordination
Soft Skills
Team CollaborationCommunication SkillsDynamic Planning Ability
Industry Keywords
Life Sciences DegreeCRO ExperienceInternational Administrative ExperienceSafety Information FlowTMF Management
About the role
Key responsibilities & impact- Serve as the main point of contact between site personnel and CRA involved in the project, helping with query resolution and EDC completion
- Serve as the primary sites’ contact point for vendors, study supplies, and access management
- Ensure completion of pre-study testing of local site facilities, including scans, MRI/CT qualification questionnaires, and test ECGs
- Assist Monitors with prompt completion of subject event and site event information in CTMS
- Track resolution status of site issues and action items in CTMS
- Manage ordering, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies
- Ensure regulatory and ethics committee submissions and notifications, staying current with local regulations and dispositions
- Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections
- Manage the TMF at site and country level and regularly file documents
- Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists
- Arrange and track initial and ongoing project training for site teams in vendor-related systems
- Review document management and translation status of the study
- Ensure proper safety information flow with investigative sites
Requirements
What you’ll need- Only CVs in English will be accepted
- College/University Degree in Life Sciences
- Administrative work experience, preferably in an international settings
- Prior experience working as CTA for CROs
- Prior experience working in Clinical Research
- Local regulations knowledge
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication and collaboration skills
Benefits
Comp & perks- Employees can work remotely
- Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company