Clinical Site Coordinator - Part Time

PSI CRO·Shymkent, Shymkent, Kazakhstan

Share role

Add a personal message

Email WhatsApp ↗

The recipient sees their own assessment. Your profile and score are not shared.

Role link

About the role

Part-time Clinical Site Coordinator supporting a clinical study site in Shymkent. Responsibilities include sponsor/CRO communication, monitoring visit support, enrollment tracking, EDC data entry, query resolution, adverse event and protocol deviation follow-up, regulatory documentation, investigational product accountability, payment and contract support, study procedures, and audit or inspection preparation. Requires a university degree in Life Science, at least two years of site coordinator experience, and fluent English and Kazakh.

Key requirements

• A university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• At least 2 years of relevant experience
• Required skills: Site coordination, Clinical trial activities, ICH-GCP compliance, Protocol adherence, Study timeline and enrollment goal management, Communication with sponsors and CROs, Monitoring visit coordination and support, Patient enrollment tracking, Clinical trial document tracking, EDC data entry, Data clarification query resolution, Adverse event reporting and follow-up, Protocol deviation reporting and follow-up, Investigational product and clinical supply accountability, Regulatory document management, Contract and budget negotiation support, Investigator and site payment support, Study procedure scheduling or performance, Audit and regulatory inspection preparation, Problem-solving, Effective communication in stressful situations
• Required languages: English, Kazakh

Opportunity details

• Workplace: On Site
• Employment: Part Time

Employer’s role description

Job title: Clinical Site Coordinator - Part Time

Location: Shymkent, Shymkent, Kazakhstan

Employment type: Part-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

The Milestone One Site Coordinator role supports a Clinical Study Site in clinical trial related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.

The function of the role may include, but not limited to, any/all of the following:

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.

Qualifications

A university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
Minimum of 2 years of on-the-job experience as a site coordinator
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.
Fluent English and Kazakh language

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.