Site Management Associate I

PSI CRO

12h

About The Position

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.

Requirements

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

Responsibilities

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.