Site Operations Coordinator
hace 1 mes
About PSI
PSI is a leading global company in the field of clinical research, and we are seeking a highly skilled Site Management Associate I to join our team.
Job Description
The ideal candidate will have excellent communication skills and experience working in an international setting. The role involves providing key support to clinical research projects by streamlining communication, maintaining systems, and managing documents and information.
Key Responsibilities:
- Act as the primary point of contact between site personnel and CRA involved in the project, assisting with query resolution and EDC completion.
- Serve as the primary sites' contact point for vendors, study supplies, and access management.
- Ensure pre-study testing of local site facilities is completed, including scans, MRI/CT qualification questionnaires, test ECGs, etc.
- Assist Monitors in completing subject event and site event information in CTMS, track the resolution status of site issues, and action items in CTMS.
- Manage the order, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies.
- Ensure regulatory and ethics committee submissions and notifications, requiring knowledge of local regulations and dispositions.
- Coordinate preparation for and follow-up on site, TMF, and systems audits and inspections.
- Manage the TMF on a site and country level, filing documents, preparing, distributing, and updating Investigator Site Files (ISF) and ISF checklists.
- Arrange and track initial and ongoing project training for site teams in vendor-related systems.
- Document Management and translations status review of the study.
- Evaluate proper safety information flow with investigative sites.
Qualifications- Bachelor's degree in Life Sciences or related field.
- Administrative work experience, preferably in an international setting.
- Prior experience working as CTA for CROs.
- Prior experience working in Clinical Research.
- Local regulations knowledge.
- Full working proficiency in English and Spanish.
- Proficiency in MS Office applications.
- Ability to plan and work in a dynamic team environment.
- Strong communication and collaboration skills.
Salary and Benefits
We offer a competitive salary range of $60,000 - $80,000 per annum, depending on experience, plus benefits, and opportunities for career advancement.
About the Role
This is an exciting opportunity to advance your career in clinical research, coordinating various tasks and learning new things while growing with the company.
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