Coordinador/a de Estudios Clinicos (CRC)

Psi CRO; Tuxpan; Sur place; MXN 300 000 - 420 000; Plein temps

Résumé du poste

Milestone One is seeking a Site Coordinator to support trial sites in all aspects per ICH-GCP guidelines and study timelines. You will act as the main liaison between the Sponsor or CRO and the site, manage feasibility responses, and assist in scheduling monitoring visits.

The role requires a Life Science degree, 2+ years in a clinical trial environment, and an upper-intermediate level of English. The position is full-time, on-site in Mexico with potential coordination across global teams.

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, with experience as a Study Coordinator or similar.
• Upper-intermediate level of English with 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.
• Flexibility in working hours depending on study procedures and patient visits.
• Strong interest in professional growth within the company.

Responsabilités

• Act as the main line of communication between the Sponsor or CRO and the site.
• Respond to feasibility questions in due time.
• Assist in scheduling and preparation for monitoring visits at the site.
• Be present and available to respond to monitors during monitoring visits.
• Track patient enrollment and support the site and CRO/Sponsor in meeting timelines.
• Maintain study documents at the site level.
• Data entry into study systems and resolve data queries promptly.
• Reportable Adverse Events and Protocol Deviations timely reporting.
• Handle, account for and reconcile investigational products and clinical supplies.
• Collect and maintain site regulatory documents as needed.
• Facilitate contract and budget negotiations at the site level.
• Support Investigator and Site payments and processes as needed.
• Schedule and perform study procedures as required.
• Prepare for and participate in audits or inspections.
• Build and sustain relationships with sponsors, CROs and institutions.

Connaissances

English (Upper-intermediate)

Communication under pressure

Problem solving

Time management

Formation

Life Science degree

Description du poste

• Full-time

Company 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.

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.

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