Coordinador/a de Estudios Clinicos (CRC)

Psicro; Tuxpan; On-site; MXN 420,000 - 550,000; Full time

Job summary

Psicro is seeking a Milestone One Site Coordinator to support trial sites in accordance with ICH-GCP and protocol requirements. You will act as the primary liaison between Sponsor/CRO and the site, managing feasibility responses and coordinating monitoring visits.

Responsibilities include tracking patient enrollment, data entry into EDC systems, regulatory document handling, and supporting contract negotiations. On-site presence and strong communication skills are essential.

Qualifications

• College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• Upper-intermediate level of English, with the ability to work in a global team environment.

Responsibilities

• 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).

Skills

Communication

English

Education

Life Science degree

Job description

Milestone One Site Coordinator

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).

Requirements

• 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.

Location: Túxpam de Rodríguez Cano (On-Site)

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.