Senior Project Coordinator (Poland)

Description

The Senior Project Coordinator works with Project Managers, Clinical Trial Managers, Site Selection Team and Clinical Research Associates (CRA) to provide administrative and coordinating support for site activation activities and other site level deliverables through all phases of the clinical trial lifecycle. As a Senior Project Coordinator, you will take the lead to ensure timeframes, targets and the quality of the deliverables are in line with internal and external customer expectations. As a Senior member of the team, you work autonomously to ensure optimized site activation and maintenance and you may be asked to mentor junior project coordinators

This role will be perfect for you if:  

• You have a minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry.
• You have proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment.… 
• You have an interest in project administration and clinical research;
• You want to have an impact in a fast-growing company.

More specifically, the Senior Project Coordinator:

• Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents.
• Establishes site activation timelines with selected sites and coordinates activities to meet planned activation timelines.
• Communicate with clinical sites during site start-up
• Collaborates with other functional departments to ensure alignment of activities to meet site activation targets
• Escalates to the Project Manager risks to site activation schedule.
• Communicates directly with the study teams, external site staff, to ensure tasks and priorities are aligned to the defined study timelines.
• Collects, reviews and files sites essential documents.
• Ensures essential documentation is complete and of good quality to successfully first pass review for site activation
• Ensures that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.
• Collects and distributes documents from / to sites
• Produces meeting minutes from project meetings.
• Maintains ADI log.
• Assigns documents for internal project-specific training and coordinates training reconciliation and documentation.
• May assist with drafting of study documents and study plans for clinical trials.
• Acts as a main point of contact for all site correspondences for non-protocol related issues.
• Assists sites with local ethics submissions.
• Assist internal and external teams with access to study-specific systems
• Assist with initiating and maintaining study files.
• Assist with assembling and shipping the Investigator’s Study File
• Maintains project timeline dates, enrolment tracking tools, and study material inventory.
• Prepares shipments of study supplies to clinical sites, when applicable.
• Assists with preparation of Investigators’ Meeting
• Distributes study correspondence to sites.
• Serves as in-house contact to support CRAs when traveling.
• Reviews and reconciles investigators site and vendor payments
• Assists with project tracking activities and status reports preparation.
• Participates in various administrative tasks as required to accomplish the goals of the project and the needs of the project team.
• May support Health Authority inspection and pre-inspection activities.
• May support audit preparation & Corrective Action / Preventative Action preparation for project related issues.
• May perform project management duties on designated trials.
• May mentor junior Project Coordinators and assist with onboarding activities.
• May assist with process improvement and creation of training material within the Site Activation and Project Coordination department. 

Requirements

Education  

• Bachelor’s degree in a field relevant to clinical research or equivalent experience.
• Specialized graduate diploma in drug development is an asset 

 

Experience  

• Minimum of 2 years of experience as a Project Coordinator or equivalent position in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry.
• Proven Site Start-Up experience in the management of clinical trials and/or staff in a global/multi-regional environment.… 

 

Knowledge and skills 

• Good knowledge of essential documentation requirements for clinical trials.
• Proficiency in English (written and oral) is required