Clinical Site Coordinator

PSI CRO·Subotica, Vojvodina, Serbia

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About the role

Milestone One seeks a Clinical Site Coordinator in Subotica to support clinical trial sites across northern Serbia. Responsibilities include coordinating sponsor/CRO and site communication, monitoring visits, enrollment, EDC data, safety and deviation reporting, investigational products, regulatory documents, site payments, study procedures, audits and inspections. The role requires a Life Science degree, at least two years of relevant clinical-trial experience, upper-intermediate English and Serbian fluency, and strong coordination and problem-solving skills.

Key requirements

• College or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.
• At least 2 years of relevant experience
• Required skills: Clinical trial coordination, Clinical terminology, Medical research, ICH-GCP compliance, Protocol implementation, Site and monitoring visit coordination, Patient enrollment tracking, EDC data entry, Data clarification query resolution, Adverse event and protocol deviation reporting, Investigational product and clinical supplies accountability, Regulatory document management, Contract and budget negotiation support, Study procedure scheduling and performance, Audit and regulatory inspection support, Stakeholder communication, Problem-solving, Upper-intermediate English, Fluency in Serbian, Flexibility in working hours for study procedures and patient visits, Strong interest in professional growth and development
• Required languages: English, Serbian

Opportunity details

• Workplace: On Site
• Employment: Other

Employer’s role description

Job title: Clinical Site Coordinator

Location: Subotica, Vojvodina, Serbia

Employment type: 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.

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:

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).
Work as a Site Coordinator for clinical trials in the northern region of Serbia.

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.
Fluency in the Serbian language.
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.