Clinical Trial Site Coordinator/ Lead Coordinator

Default

Almaty, Kazakhstan

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.

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:

• 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).
• Support Site Development Manager with active promotion of Milestone One brand by acquiring new clinics and building a site network.
• Conduct research on potential clients to build extended network.
• Set up meetings with potential clients to present MO1 business opportunities and benefits of cooperation with Milestone One

Qualifications

• College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• Prior experience in coordinating clinical trials on site or a similar role in clinical research is prefer
• 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.

Offer:

• 800 000 – 1 000 000 KZT net per month.
• Employment Benefits: bonuses based on results of a past year and social medical insurance for employee and members of his family.
• Probation period 3 months as per labor legislation of KZ.
• Working hours: 8.00 am – 17.30 pm as per working time in the site. We have 6-8 month for preparation period for the project with limited working time.
• Location: office inside of site, Almaty.

Please submit CV in English.