Site Coordinator

PSI CRO; Tuxpan; Presencial; MXN 180.000 - 280.000; Jornada completa

Descripción de la vacante

Milestone One is a Site Enabling Services organization seeking a Site Coordinator to support trial sites in line with ICH-GCP and protocol timelines.

You will act as the main communication link between Sponsor/CRO and the site, manage feasibility responses, schedule visits, monitor enrollment, and ensure regulatory documents are maintained. A fast-paced, global team environment awaits.

Formación

• Bachelor-level degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• 2+ years in a clinical trial environment as a Study Coordinator or similar function.
• Upper-intermediate English; able to work in a global team.

Responsabilidades

• Act as main line of communication between Sponsor or CRO and the site.
• Ensure timely response to feasibility questions.
• Assist scheduling and preparation for monitoring visits at the site.
• Be present and respond to monitors during visits.
• Track patient enrollment and support timelines and enrollment goals.
• Maintain study documents at the site level.
• Accurate data entry into EDC systems and resolve data queries.
• Timely reporting of Adverse Events and Protocol Deviations.
• Handle investigational products and clinical supplies; ensure accountability.
• Collect and maintain all site regulatory documents.
• Facilitate contract and budget negotiations at the site level.
• Support Investigator and Site payments and processes.
• Schedule or perform study procedures as required.
• Prepare for onsite audits or regulatory inspections.
• Build and sustain relationships with sponsors, CROs, and medical institutions.

Conocimientos

English (Upper-Intermediate)

Communication under stress

Multi-tasking in fast-paced env

Problem-solving

Educación

BSc in Life Science or related field

Descripción del empleo

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.

Job Description

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:

• Actas the main line of communication between the Sponsor or CRO and the site.
• Ensureresponse to feasibility questions are provided in due time.
• Assistin scheduling and preparation for all types of monitoring visits at the medical institution/research center.
• Be present and available to respond to monitors duringall types of monitoring visits conducted at the medical institution.
• Trackpatient enrollment and actively supportthe medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.
• Maintainstudy 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, handleand maintainall site-specific regulatory documents as needed.
• Facilitateand support the contract and budget negotiations at the site level.
• SupportInvestigator and Site payments and processes as needed.
• Scheduleand/or performstudy procedures as per study requirements and delegation of responsibilities.
• Preparefor and participatein onsite study audits or regulatory agency inspections.
• Buildand sustainlong-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).

Qualifications

• College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• Minimum of 2 years of on-the-job experience in a clinical trial environment, where relevant experience has been gained in clinical trials, clinical terminology, and medical research working in the role of a Study Coordinator or similar function.
• Upper-intermediate level of English, with the ability to work in a global team environment.
• Experience in Nephrology clinical studies is a plus.
• Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously.
• Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.
• Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.
• Strong interest in professional growth and development within the company.

Additional Information

If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you.