PSI CRO
Pharmaceuticals
SiteManagementAssociate
Neural analysis suggests this role is
optimal for entry candidates.
“Site Management Associate at PSI CRO. Skills: Site management, Clinical operations, Regulatory compliance. Serve as main point of contact. Assist site personnel with query resolution”
Industry & Context.
Query resolution
What They're Looking For.
Must Have
College/University Degree in Life, Administrative work experience, Prior experience working as CTA, Prior experience working in Clinical, Local regulations knowledge, Full working proficiency in English, Proficiency in MS Office
What You'll Do.
Serve as main point of contact
Assist site personnel with query resolution
Assist site personnel with EDC completion
Serve as primary sites’ contact point
Manage study supplies
Ensure pre-study testing completion
Assist Monitors with CTMS completion
Track resolution status of site issues
Track action items in CTMS
Ensure order of clinical supplies
Ensure receipt of clinical supplies
Ensure inventory storage of clinical supplies
Ensure distribution of clinical supplies
Ensure return/recall of clinical supplies
Ensure reconciliation of clinical supplies
Ensure regulatory submissions
Ensure ethics committee submissions
Coordinate preparation for audits
Coordinate preparation for inspections
Follow-up on site audits
Follow-up on TMF audits
Follow-up on systems audits
Follow-up on site inspections
Follow-up on TMF inspections
Follow-up on systems inspections
Manage TMF on site level
Manage TMF on country level
File documents regularly
Prepare Investigator Site Files
Distribute Investigator Site Files
Update Investigator Site Files
Prepare ISF checklists
Distribute ISF checklists
Update ISF checklists
Arrange project training for site teams
Track project training for site teams
Arrange vendor-related systems training
Track vendor-related systems training
Review document management status
Review translations status
Ensure safety information flow
How You'll Work.
Team & Collaboration
Site personnel; CRA; Monitors; Site teams; International team
Process & Methodology
Project coordination
Full Job Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. 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 Life Sciences; * Administrative
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