Senior Site Navigator

Budapest - Hungary

Monthly Salary: Not Disclosed

Posted on: 23 hours ago

Vacancies: 1 Vacancy

Job Summary

Fortrea is looking for a Senior Site Navigator to join its Hungarian team!

You will be responsible for:

Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines local regulations SOPs and project requirements including collaboration with project leadership and local monitors to collaboratively achieve project milestones while also ensuring patient rights wellbeing and safety are protected
Identifying potential research sites that align with the studys criteria and assessing their capabilities and resources.
Conduct initial site outreach i.e. site engagement collection of Confidentiality Agreement and feasibility survey
Remote Pre-Study Visits and follow up documentation including visit preparation trip report completion and other documentation as required to support site selection in line with sponsor protocol local and country regulations and requirements
Support customization and translation of informed consent forms and patient-facing materials.
Collect track and perform a quality review of all essential documents required for effective and compliant study site activation from Site outreach submissions greenlight and until site activation. Maintenance and ongoing awareness of site regulatory compliance supporting annual IRB/Independent Ethics Committee (IEC) renewals PI change-over and document expirations will be performed as applicable in compliance with local requirements.
Actively participate in study team meetings to support study progress develop and implement action plans for site level risks underperforming sites or issues impacting project milestones and escalate issues in a timely manner
Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors supplies teams and study leads to ensure timely distribution of clinical study supplies accesses and documents per study team guidance.
Responsible for submissions to and liaise with applicable IRB/IEC Third Bodies (if applicable) and Regulatory Authorities by collaborating with Global Regulatory Submissions Lead(GRSL).
Perform initial contract and budget negotiations with the sites as well as amended where applicable
Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times.
Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines
Ensure Fortrea is audit ready by completing accurate timely and consistent system compliance on an ongoing basis
Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget
Perform Case Review Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations Serious Adverse Event (SAE) reporting and all other duties as needed or assigned throughout the course of the study.
Perform country and site ICF review/customization per local requirements
All other duties as needed or assigned

Qualifications (Minimum Required):

University/College degree (life science preferred) or certification in a related allied health profession from an appropriate accredited institution (e.g. nursing certification medical or laboratory technology) or 3-5 years work experience in clinical research including a strong working knowledge of the ICH/GCP guidelines and RA IRB/IEC regulations.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
In lieu of the above requirement candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research including a strong working knowledge of the ICH/GCP guidelines and RA IRB/IEC regulations will be considered.
Fluent in local official language and in English both written and verbal.

Your experience (Minimum Required):

A scientific degree and/ or clinical expertise is optimal for this role.
Minimum of 3 years of experience in clinical development or start-up/ regulatory process.
Thorough knowledge of ICH/GCP RA IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.
Effective communication with various stakeholders including site staff CRO personnel and regulatory authorities.
Ability to manage multiple tasks and deadlines simultaneously ensuring that all requirements are met in a timely manner.
Understanding of relevant regulations and guidelines related to clinical trials and research.
Ability to identify and resolve potential issues that may arise during the start-up process.
Ability to negotiate contracts and budgets effectively with research sites.

Work Environment:

Remote-based workrequiredwithpossible officepresence
depending on location
Travel requirements: Limited for training only

Learn more about our EEO & Accommodations request here.

Required Experience:

Senior IC

Fortrea is looking for a Senior Site Navigator to join its Hungarian team! You will be responsible for:Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines local regulations SOPs and project requirements including collaboration with project le...

Fortrea is looking for a Senior Site Navigator to join its Hungarian team!

You will be responsible for:

Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines local regulations SOPs and project requirements including collaboration with project leadership and local monitors to collaboratively achieve project milestones while also ensuring patient rights wellbeing and safety are protected
Identifying potential research sites that align with the studys criteria and assessing their capabilities and resources.
Conduct initial site outreach i.e. site engagement collection of Confidentiality Agreement and feasibility survey
Remote Pre-Study Visits and follow up documentation including visit preparation trip report completion and other documentation as required to support site selection in line with sponsor protocol local and country regulations and requirements
Support customization and translation of informed consent forms and patient-facing materials.
Collect track and perform a quality review of all essential documents required for effective and compliant study site activation from Site outreach submissions greenlight and until site activation. Maintenance and ongoing awareness of site regulatory compliance supporting annual IRB/Independent Ethics Committee (IEC) renewals PI change-over and document expirations will be performed as applicable in compliance with local requirements.
Actively participate in study team meetings to support study progress develop and implement action plans for site level risks underperforming sites or issues impacting project milestones and escalate issues in a timely manner
Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors supplies teams and study leads to ensure timely distribution of clinical study supplies accesses and documents per study team guidance.
Responsible for submissions to and liaise with applicable IRB/IEC Third Bodies (if applicable) and Regulatory Authorities by collaborating with Global Regulatory Submissions Lead(GRSL).
Perform initial contract and budget negotiations with the sites as well as amended where applicable
Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times.
Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines
Ensure Fortrea is audit ready by completing accurate timely and consistent system compliance on an ongoing basis
Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget
Perform Case Review Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations Serious Adverse Event (SAE) reporting and all other duties as needed or assigned throughout the course of the study.
Perform country and site ICF review/customization per local requirements
All other duties as needed or assigned

Qualifications (Minimum Required):

University/College degree (life science preferred) or certification in a related allied health profession from an appropriate accredited institution (e.g. nursing certification medical or laboratory technology) or 3-5 years work experience in clinical research including a strong working knowledge of the ICH/GCP guidelines and RA IRB/IEC regulations.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
In lieu of the above requirement candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research including a strong working knowledge of the ICH/GCP guidelines and RA IRB/IEC regulations will be considered.
Fluent in local official language and in English both written and verbal.

Your experience (Minimum Required):

A scientific degree and/ or clinical expertise is optimal for this role.
Minimum of 3 years of experience in clinical development or start-up/ regulatory process.
Thorough knowledge of ICH/GCP RA IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.
Effective communication with various stakeholders including site staff CRO personnel and regulatory authorities.
Ability to manage multiple tasks and deadlines simultaneously ensuring that all requirements are met in a timely manner.
Understanding of relevant regulations and guidelines related to clinical trials and research.
Ability to identify and resolve potential issues that may arise during the start-up process.
Ability to negotiate contracts and budgets effectively with research sites.

Work Environment: