The Project Assistant provides administrative and coordination support to the Project Management and Clinical Operations teams throughout various stages of clinical studies. This is an entry-level position, ideal for individuals beginning their career in clinical research. The incumbent works under close supervision to support project deliverables and ensure quality and compliance in study documentation.
More specifically, the Project Assistant must:
- Prepare, review, and submit essential clinical trial and regulatory documents required for site activation under supervision.
- Assist with the collection, organization, and maintenance of site regulatory documents in CTMS and eTMF.
- Track and update project timelines, site status, and study milestones in project tracking systems.
- Support the project team with assembling, shipping, and reconciling Investigator Study Files (ISFs).
- Assist with study start-up, maintenance, and close-out activities, ensuring proper documentation throughout the trial lifecycle.
- Maintain project-related logs (e.g., ADI, training, site visit, and correspondence logs).
- File and organize email correspondence and visit reports in the eTMF to ensure audit readiness.
- Participate in internal project meetings and take meeting minutes as required.
- Coordinate the completion and tracking of study-specific training and assist with SOLABS reconciliation.
- Communicate with internal team members and occasionally external partners for follow-up on outstanding documentation.
- Provide general administrative and logistical support to Project Coordinators, Project Managers, and Clinical Operations.
- Adhere to SOPs, Good Clinical Practice (GCP), and regulatory guidelines to ensure compliance.
Requirements
- College or bachelor’s degree.
- Experience in clinical research or a CRO/pharma environment is an asset.
- Proficiency in English (written and oral); bilingualism is an asset.
- Good knowledge of Microsoft Office (Word, Excel, PowerPoint).
- Strong attention to detail and organizational skills.
- Demonstrates learning agility, adaptability, and the ability to manage multiple priorities.
Our company
The work environment
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:
- Flexible work schedule
- 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 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 Romania.
Description - Fr
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Profil recherché
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Notre entreprise
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Top Skills
What We Do
As a CRO (Contract Research Organization) specialized in dermatology and rheumatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site.
The design and conduct of Phase I to Phase IV studies is our core expertise.
Our specialized services include:
• Study Design and Protocol Development
• Submission to Regulatory Agencies and Central Ethics Committees
• Regulatory Consulting
• Trial Master Files Management
• Project Management
• Investigator / Site Selection
• Patient Recruitment
• Clinical Monitoring
• Medical Monitoring
• Pharmacovigilance
• Data Management
• Biostatistical Analysis
• Clinical Study Report
• Medical Writing / Publication
Since 2000, Innovaderm has built a strong reputation for the quality of its research and the care offered to its study participants, its clients and its sites, often exceeding our client’s timeline expectations.
