PSI CRO

Pharmaceuticals

ClinicalTrialsLeadSiteCoordinator

$365–545k ~AI est. Mexico City, CDMX, Mexico FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for mid candidates.

The Brief

“Clinical Trials Lead Site Coordinator at PSI CRO. Skills: Site coordination, Clinical study support, Client relationships. Act as main line of communication. Ensure response to feasibility questions”

What You'll Achieve.

Meet project timelines; Meet enrollment goals

Industry & Context.

Pharmaceuticals
Problems you'll solve

Problem-solve in an effective manner; Problem-solve in an efficient manner

Eligibility Requirements

Flexibility in working hours

What They're Looking For.

Must Have

College or university degree, Minimum of 2 years of on-the-job experience in a clinical trial environment, Relevant experience in clinical trials, Relevant experience in clinical terminology, Relevant experience in medical research, Experience in the role of a Study Coordinator or similar function, Upper-intermediate level of English

Nice to Have

Experience in Oncology, Experience in Renal, Experience in Cardiology clinical studies, Interest in professional growth and development

What You'll Do.

Act as main line of communication

Ensure response to feasibility questions

Assist in scheduling monitoring visits

Assist in preparation for monitoring visits

Be present during monitoring visits

Respond to monitors during visits

Track patient enrollment

Support meeting project timelines

Support meeting enrollment goals

Maintain study specific tracking of documents

Maintain general tracking of documents

Accurate data entry into EDC systems

Timely resolution of data clarification queries

Timely reporting on adverse events

Timely reporting on protocol deviations

Follow up on adverse events

Follow up on protocol deviations

Proper handling of investigational products

Proper handling of clinical supplies

Accountability of investigational products

Accountability of clinical supplies

Reconciliation of investigational products

Reconciliation of clinical supplies

Collect site-specific regulatory documents

Handle site-specific regulatory documents

Maintain site-specific regulatory documents

Facilitate contract negotiations

Facilitate budget negotiations

Support Investigator payments

Support Site payments

Support Investigator processes

Support Site processes

Schedule study procedures

Perform study procedures

Prepare for onsite study audits

Participate in onsite study audits

Prepare for regulatory agency inspections

Participate in regulatory agency inspections

Build client relationships

Sustain client relationships

How You'll Work.

Team & Collaboration

Global team environment; Site and CRO/Sponsor team

Communication Scope

Communication in stressful situations

Full Job Description

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Please submit CV in English. Milestone One Site Coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals. In this role you will: * Act as the main line of communication between the Sponsor or CRO and the site. * Ensure response to feasibility questions are provided in due time. * Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center. * Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution. * Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals. * Maintain study specific and general tracking of documents at the site level. * Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site. * Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations. * Proper handling, accountability and reconciliation of investigational products and clinical supplies. * Collect, handle and maintain all site-specific regulatory documents as needed. * Facilitate and support the contract and budget negotiations at the site level. * Support Investigator and Site payments and processes as needed. * Schedule and/or perform study procedures as per study requirements and delegation of responsibilities. * Prepare for and participate in onsite study audits or regulatory agency inspections. * Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions). ## Qualifications * College or university degree in Life Science

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