Remote Centralized Monitoring Lead (Clinical Trials)

Syneos Health, Inc.; Ciudad de Mendoza; Remote; ARS 600,000 - 1,000,000; Full time

Job summary

Syneos Health, Inc. is seeking a Milestone One Site Coordinator in Mendoza, Argentina, to support trial sites in line with ICH-GCP and protocol timelines. You will serve as the main contact between Sponsor/CRO and sites, and help with feasibility responses and monitoring visits.

You will track enrollment, manage regulatory documents, and assist in site budgeting and payments, while ensuring data entry and QA for study systems and regulatory compliance.

Qualifications

• College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• Minimum of 3 years of on-the-job experience in a clinical trial environment, with relevant experience in trials and medical research.
• Upper-Intermediate level of English, with the ability to work in a global team.
• Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously.
• Ability to communicate effectively under stress and solve problems efficiently.
• Flexibility in working hours may be required depending on study procedures and patient visits.

Responsibilities

• Act as the main line of communication between the Sponsor or CRO and the site.
• Ensure responses 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 monitoring visits at the medical institution.
• Track patient enrollment and support the site and CRO/Sponsor team in meeting timelines and enrollment goals.
• Maintain study-specific and general tracking of documents at the site.
• Accurate data entry into study-specific EDC systems and timely resolution of data clarification queries.
• Timely reporting of Adverse Events and Protocol Deviations.
• Proper handling and reconciliation of investigational products and clinical supplies.
• Collect and maintain site-specific regulatory documents as needed.
• Facilitate 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.
• Prepare for and participate in onsite study audits or regulatory inspections.
• Build and sustain relationships with sponsors, CROs, and medical institutions.

Skills

English (Upper-Int)

Communicating under pressure

Fast-paced environment

Education

Life Science degree

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).

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 3years 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-Intermediatelevel of English, with the ability to work in a global team environment.
• 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!