Site Management Associate I
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 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.
Qualifications :
- College/University Degree in Health Sciences;
- Administrative work experience;
- Prior experience working in Clinical Research;
- Local regulations knowledge;
- Full working proficiency in English and Portuguese;
- Proficiency in MS Office applications;
- Ability to plan and work in a dynamic team environment;
- Communication and collaboration skills.
Additional Information :
Advance your career in clinical research coordinating a variety of tasks and learning new things while growing with the company.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
