Site Management Associate I
RemoteUnited States or Argentina
Job Summary
Conduct daily site management by serving as the primary contact between site personnel, CRAs, and vendors to streamline communication and resolve queries. Ensure pre-study testing completion, manage clinical supply inventory and distribution, and track event information in CTMS. Coordinate regulatory submissions, prepare for audits, maintain TMF and Investigator Site Files, and arrange project training. Manage document management and translations while ensuring proper safety information flow with investigative sites. Requires a Life Sciences degree, prior CRO experience, and local regulations knowledge. Full English proficiency and MS Office skills are essential for this international role within a global clinical research team.
Required Qualifications
- Only CVs in English will be accepted
- Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion
- Serves as the primary sites' contact point for vendors, study supplies, and access management
- Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
- Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS
- Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
- Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on 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 a country level for regularly and file documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists
- Arrange and track initial and on-going project training for site teams in all vendor-related systems
- Document Management and translations status review of the study
- Ensures proper safety information flow with investigative sites
- 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
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