Job Overview:
Location: Warsaw (hybrid role)
We are looking for a clinical operations professional to join our team as Site Navigator I managing clinical trial startup activities with additional inhouse CRA responsibilities. This is an excellent comprehensive role for someone looking to grow their career in clinical research within a global CRO environment.
Summary of Responsibilities:
Perform site identification feasibility and startup activities including site outreach feasibility questionnaires and confidentiality agreements
Coordinate and track essential regulatory documents to ensure timely and compliant site activation
Act as a primary point of contact for investigative sites during the startup and occasionally the maintenance phase
Perform ethics committee and regulatory authority/EU CTR submissions renewals and prepare the relevant regulatory documentation in collaboration with internal teams
Perform site contracts and budget negotiations under guidance
Perform remote Pre-Study Visits
Support Site Initiation Visit (SIV) preparation including coordination of documents systems access and study supplies
Perform remote/inhouse CRA activities such as document review CRF review data validation and remote monitoring tasks (after required training)
Maintain accurate documentation in study systems and ensure the TMF is inspectionready
Collaborate closely with CRAs project teams and study stakeholders to support study milestones
Qualifications (Minimum Required):
University degree (life sciences preferred)
Minimum 1 year experience in Clinical Operations or Start-Up
Knowledge of ICH/GCP and clinical trial processes
Fluent Polish and English (written and spoken)
Strong organizational skills attention to detail effective communication and willingness to learn
Ability to manage multiple tasks in a structured and proactive way
Learn more about our EEO & Accommodations request here.
Job Overview:Location: Warsaw (hybrid role)We are looking for a clinical operations professional to join our team as Site Navigator I managing clinical trial startup activities with additional inhouse CRA responsibilities. This is an excellent comprehensive role for someone looking to grow their car...
Job Overview:
Location: Warsaw (hybrid role)
We are looking for a clinical operations professional to join our team as Site Navigator I managing clinical trial startup activities with additional inhouse CRA responsibilities. This is an excellent comprehensive role for someone looking to grow their career in clinical research within a global CRO environment.
Summary of Responsibilities:
Perform site identification feasibility and startup activities including site outreach feasibility questionnaires and confidentiality agreements
Coordinate and track essential regulatory documents to ensure timely and compliant site activation
Act as a primary point of contact for investigative sites during the startup and occasionally the maintenance phase
Perform ethics committee and regulatory authority/EU CTR submissions renewals and prepare the relevant regulatory documentation in collaboration with internal teams
Perform site contracts and budget negotiations under guidance
Perform remote Pre-Study Visits
Support Site Initiation Visit (SIV) preparation including coordination of documents systems access and study supplies
Perform remote/inhouse CRA activities such as document review CRF review data validation and remote monitoring tasks (after required training)
Maintain accurate documentation in study systems and ensure the TMF is inspectionready
Collaborate closely with CRAs project teams and study stakeholders to support study milestones
Qualifications (Minimum Required):
University degree (life sciences preferred)
Minimum 1 year experience in Clinical Operations or Start-Up
Knowledge of ICH/GCP and clinical trial processes
Fluent Polish and English (written and spoken)
Strong organizational skills attention to detail effective communication and willingness to learn
Ability to manage multiple tasks in a structured and proactive way
Learn more about our EEO & Accommodations request here.
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