PSI CRO

Pharmaceuticals

SiteManagementAssociate

$485–725k ~AI est. Mexico City, CDMX, Mexico FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for entry candidates.

The Brief

“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.

Pharmaceuticals
Problems you'll solve

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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