Senior Project Coordinator

4 tygodni temu

Warszawa, Mazovia, Polska Innovaderm Research Pełny etat
About the Role

We are seeking a highly skilled and experienced Senior Project Coordinator to join our team at Innovaderm Research. As a Senior Project Coordinator, you will play a key role in the management of clinical trials and site activation activities.

Key Responsibilities
  • 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.
About Innovaderm Research

Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We have a solid reputation for the quality of our research and services, and we continue to grow and expand in North America and Europe.

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

We only accept applicants who can legally work in Poland.

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

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