Senior Project Coordinator (Poland)

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.
• Establish site activation timelines with selected sites and coordinates activities to meet planned activation timelines.
• Communicate with clinical sites during site start-up.
• Collaborate with other functional departments to ensure alignment of activities to meet site activation targets.
• Escalate to the Project Manager risks to site activation schedule.
• Communicate directly with the study teams, external site staff, to ensure tasks and priorities are aligned to the defined study timelines.
• Collect, review and file sites essential documents.
• Ensure essential documentation is complete and of good quality to successfully first pass review for site activation.
• Ensure that the electronic Trial Master File (eTMF) contains the relevant regulatory documents for site activation and ongoing study management.
• Collect and distribute documents from/to sites.
• Produce meeting minutes from project meetings.
• Maintain ADI log.
• Assign documents for internal project-specific training and coordinate training reconciliation and documentation.
• May assist with drafting of study documents and study plans for clinical trials.
• Act as a main point of contact for all site correspondences for non-protocol related issues.
• Assist 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.
• Maintain project timeline dates, enrolment tracking tools, and study material inventory.
• Prepare shipments of study supplies to clinical sites, when applicable.
• Assist with preparation of Investigators’ Meeting.
• Distribute study correspondence to sites.
• Serve as in-house contact to support CRAs when traveling.
• Review and reconcile investigators site and vendor payments.
• Assist with project tracking activities and status reports preparation.
• Participate 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.
• Bilingual French and English or fluency in another European or Asian language is an asset.
• Excellent knowledge and competency in Word, Excel, and Power Point.
• Ability to prioritize multiple assignments to meet deadlines.
• Attention to detail.
• Quick learner, good adaptability and versatile.
• Strong organizational, communication, problem-solving and multi-tasking skills.
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

OUR COMPANY

The work environment

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Permanent full-time position
• Vacation, PPK, health allowance
• Home-based position with teleworking allowance
• Ongoing learning and development

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Innovaderm only accepts applicants who can legally work in Poland.