Remote Centralized Monitoring Lead - Global Study Manager

Parexel International; Ciudad de Mendoza; Remote; ARS 900,000 - 1,300,000; Full time

Job summary

Parexel International is seeking a Milestone One Site Coordinator to support trial sites, ensuring compliance with ICH-GCP and protocol timelines. The role involves communication with sponsors/CROs, preparing for monitoring visits, and tracking enrollment goals.

The candidate will manage data entry in EDC, maintain regulatory documents, and assist in site contracts, budgets, and payments while coordinating procedures and audits as required.

Qualifications

• Bachelor's degree in Life Sciences or equivalent required.
• Experience in a clinical trial environment, role of Study Coordinator or similar.

Responsibilities

• Act as the main line of communication between Sponsor/CRO and the site.
• Respond to feasibility questions in a timely manner.
• Assist in scheduling and preparation for monitoring visits at the site.
• Be present and respond to monitors during visits at the site.
• Track patient enrollment and support timelines and enrollment goals.
• Maintain study-specific and general document tracking at the site level.
• Enter data accurately into study EDC systems and resolve data queries promptly.
• Report and follow up on Adverse Events and Protocol Deviations.
• Handle, reconcile and account for investigational products and clinical supplies.
• Collect and maintain site regulatory documents as needed.
• Support contract and budget negotiations at the site level.
• Assist Investigator and Site payments and processes as needed.
• Schedule and perform study procedures per requirements and delegation of responsibilities.
• Prepare for and participate in onsite audits or regulatory inspections.
• Build and sustain relationships with sponsors, CROs, and medical institutions.

Skills

English (Upper-Intermediate)

Clinical trial coordination

Education

Bachelor's degree in Life Sciences

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!