Site Management Associate I
Site Management Associate I
Posted on :
20-12-2024
Employer Active
1 Vacancy
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Job Description
Join our international team and be the key support to clinical research projects streamlining communication maintaining systems and managing documents & information.
Only CVs in English will be accepted.
You will be responsible for:
- 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 prestudy 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 followup 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 ongoing project training for site teams in all vendorrelated systems.
- Document Management and translations status review of the study.
- Ensures proper safety information flow with investigative sites.
Qualifications :
- 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 and Spanish;
- Proficiency in MS Office applications;
- Ability to plan and work in a dynamic team environment;
- Communication and collaboration skills.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Key Skills
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