Clinical Research Coordinator (CRC)

PSI CRO; Tuxpan; On-site; MXN 260,000 - 420,000; Full time

Job summary

Milestone One is seeking a Site Coordinator to support trial sites in all activities per ICH-GCP, within study-defined timelines and enrollment goals.

You will act as the main liaison between Sponsor/CRO and the site, assist in monitoring visits, data entry into study systems, regulatory documents, site budgets, and audits. English proficiency and a Life Science degree are required, with 2+ years in clinical trials preferred.

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 as a Study Coordinator or similar.
• Upper-intermediate English, able to work in a global team.
• Experience in nephrology studies is a plus.
• Ability to work in a fast-paced environment with tight timelines and multiple tasks.
• Strong communication and problem-solving in stressful situations.
• Flexibility in working hours as study procedures and patient visits require.

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.
• Be present to respond to monitors during visits.
• Track patient enrollment and support timelines and enrollment goals.
• Maintain study and general site-level document tracking.
• Data entry into study-specific EDC systems and resolve data clarifications.
• Report and follow up on Adverse Events and Protocol Deviations.
• Handle, account for, and reconcile investigational products and supplies.
• Collect and maintain site regulatory documents.
• Support contract and budget negotiations at the site level.
• Assist Investigator and Site payments and processes as needed.
• Schedule and/or perform study procedures as required.
• Prepare for and participate in audits or inspections.
• Build relationships with sponsors, CROs, and medical institutions.

Skills

English proficiency

Team collaboration

Communication under stress

Problem solving

Education

Life Science degree

Job 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.