Project Coordinator (Spain)

Indero (formerly Innovaderm); Madrid; Híbrido; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company as a Project Coordinator, where you will play a crucial role in supporting clinical trials. This position offers the chance to work in a collaborative environment, ensuring that site activation activities align with both internal and external expectations. You'll be responsible for preparing sites for trials, managing timelines, and facilitating communication between teams. With a commitment to innovation and excellence, this dynamic firm provides an exciting opportunity to make a significant impact in the fast-growing field of clinical research. If you are organized, detail-oriented, and passionate about improving patient outcomes, this role is perfect for you.

Servicios

Permanent full-time position

Flexible schedule

Vacation

Home-based position

Ongoing learning and development

Formación

• Bachelor’s degree in a relevant field or equivalent experience is required.
• Experience in clinical research and biotechnology is an asset.

Responsabilidades

• Prepare Investigator Sites for clinical trials and ensure regulatory compliance.
• Establish site activation timelines and coordinate activities.
• Communicate with clinical sites and manage documentation.

Conocimientos

Project Administration

Clinical Research

English Language Proficiency

German Language Proficiency

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Organizational Skills

Problem-Solving Skills

Multi-tasking Skills

Educación

Bachelor’s degree in a relevant field

Graduate diploma in drug development

Herramientas

Microsoft Office Suite

Descripción del empleo

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

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.
• Establish site activation timelines with selected sites and coordinate 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 and 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 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.

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:

• Experience in clinical research and in the biotechnology, pharmaceutical, and/or CRO industry is an asset.

Skills:

• Excellent oral and written skills in English.
• German language proficiency is an asset due to frequent interactions with clinical sites in German-speaking countries.
• Excellent knowledge and competency in Word, Excel, and PowerPoint.
• Ability to prioritize different assignments and work under pressure.
• Attention to detail and meet timelines.
• Quick learner, good adaptability, and versatile.
• Strong organizational, communication, problem-solving, and multi-tasking skills.

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 full-time position.
• Flexible schedule.
• Vacation.
• Home-based position.
• Ongoing learning and development.

About Indero:

A Global Clinical Leader In Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned 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 dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service 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 a 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.