Project Coordinator (Spain)

Description

The 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 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

This role is perfect for you if:

• You have an experience in project administration and clinical research;
• You want to work in a collaborative environment;
• You want to have an impact in a fastgrowing company.

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  RESPONSIBILITIES

  More specifically, the 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 startup.
  • 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 projectspecific 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 nonprotocol related issues.
  • Assists sites with local ethics submissions.
  • Assist internal and external teams with access to studyspecific 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 inhouse 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 preinspection activities.
  • May support audit preparation & Corrective Action Preventative Action preparation for project related issues.
  • May perform project management duties on designated trials.

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    Requirements

    Education

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

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      Experience

      • Experience in clinical research and in the biotechnology, pharmaceutical, andor CRO industry, an asset;

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        Skills

        • Excellent oral and written skills in English
        • German language proficiency is an asset due to frequent interactions with clinical sites in Germanspeaking countries.
        • Excellent knowledge and competency in Word, Excel and Power Point;
        • Ability to prioritize different assignments and work under pressure;
        • Attention to detail and meet timelines;
        • Quick learner, good adaptability and versatile;
        • Strong organizational, communication, problemsolving and multitasking skills.

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          Our company

          At Indero, 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 fulltime position
          • Flexible schedule
          • Vacation
          • Homebased position
          • Ongoing learning and development

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            About Indero

            A Global Clinical Leader In Dermatology!

            Formerly known as Innovaderm, Indero is a worldrenowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

            
            

            Indero is a dualfocus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our fullservice approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

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

            
            

            Indero only accepts applicants who can legally work in Spain.