TFS HealthScience - Contract Research Organization

Research Analyst

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations
• Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
• Verify proper management and accountability of Investigational Product
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate
• Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner
• Timely delivering site documents to eTMF or paper TMF
• Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements

Senior Clinical Research Associate

Project Manager

• Lead end-to-end project delivery ensuring timelines, scope, and budget are met
• Manage cross-functional teams (Clinical, Data Management, Regulatory, etc.)
• Identify, assess, and mitigate project risks
• Develop and maintain detailed project plans and timelines
• Act as the main point of contact for clients and stakeholders
• Monitor project performance, including financials and profitability
• Ensure compliance with internal SOPs and regulatory requirements
• Allocate and manage project resources in collaboration with line managers
• Report progress and escalate issues where needed
• Support business development activities, including proposals and bid defenses
• Mentor junior Project Managers when required

Senior Project Manager

• Perform on-site and remote monitoring visits to ensure subject safety and data quality
• Review CRFs and source documentation for accuracy and completeness
• Ensure informed consent procedures and protocol compliance are met
• Manage and track Investigational Product accountability
• Prepare monitoring visit reports and follow up on action items
• Maintain and update eTMF, CTMS, and trial documentation systems
• Support sites with issue resolution and ensure timely completion of deliverables
• Participate in audits and inspections, including preparation and follow-up
• Collaborate with project teams and contribute to monitoring plans, project tracking, and CRA resource planning

Data Entry

• Perform accurate and timely data entry into study systems in line with protocols and SOPs
• Support query resolution and ensure data quality and completeness
• Assist with Serious Adverse Event reporting activities
• Maintain and update Investigator Site Files and study documentation
• Support Ethics Committee submissions and regulatory documentation
• Assist with study drug accountability logs and tracking
• Support monitoring visits, audits, and inspections when required
• Manage patient expense documentation and administrative follow up
• Provide general administrative support to the study team as needed

Site Coordinator, Data Entry

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.
• Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy.
• Verify proper management and accountability of Investigational Product.
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
• Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
• Timely delivering site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
• Participate in audit and/or inspection, its preparation and follow-up activities, as needed.
• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
• Update CTMS and all other required by projects systems with accurate site level information.

Clinical Research Associate – Freelance

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard.
• Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy.
• Verify proper management and accountability of Investigational Product.
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
• Monitoring Close-out visits in Ukraine.

Senior Clinical Research Associate

Senior Project Manager

Senior Clinical Research Associate

Site Coordinator, Data Entry

Clinical Research Associate – Freelance

Senior Clinical Research Associate – Freelance