Clinical Research Associate

InhaTarget Therapeutics is a spin-off company from the University of Brussels (ULB)
- Belgium, dedicated to the early development and clinical validation of innovative treatments of pulmonary diseases by inhalation, with a first focus on lung cancer. The company was established in August 2019 and brings together strong complementary expertise in drug formulation, inhalation delivery, immunology, preclinical development and clinical operations. The company is currently located on two sites:
- the corporate headquarters in Gosselies (South of Brussels
- Biopark), where pre-clinical and clinical activities are performed;
- ULB’s Unit of Pharmaceutics and Biopharmaceutics (Brussels) which incubates some R&D activities related to formulation and pharmaceutical product development. The position at stake will be mainly located in Gosselies. The company currently consists of a team of seven people: the CEO, CSO, Director of Clinical Operations, two Scientists, an Analytical Laboratory Manager and an Analytical Technician. In addition to its internal team, the company works closely with a network of specialized preclinical, clinical and CMC subcontractors, CROs and consultants. Reporting to and working closely with the Director of Clinical Operations, the CRA–CTA will play an important operational role in the execution of the company’s clinical development activities. This is a broad and hands-on position combining clinical trial support, site management, monitoring and clinical documentation activities. Given the size of the organization, the successful candidate will have direct exposure to multiple aspects of clinical development and will interact regularly with investigational sites, CROs, laboratories, vendors and consultants. The position is particularly suited to an early-career clinical research professional who already has solid clinical trial experience and is looking to broaden their responsibilities and progressively develop toward an autonomous CRA / Clinical Operations role within a biotech environment.

Key Responsibilities
Clinical Trial Operations & Support
- Support study start-up activities, including collection and review of essential documents and coordination of site activation activities.
- Prepare, collect, review and track clinical trial documentation throughout the study lifecycle.
- Maintain the Trial Master File (TMF/eTMF) and support sites in maintaining complete and inspection-ready Investigator Site Files.
- Track key study milestones, patient recruitment, site performance, outstanding documentation and study-related action items.
- Support the Director of Clinical Operations in the day-to-day management and execution of clinical studies.
- Support operational activities with investigational sites, CROs, central laboratories, clinical vendors and consultants.
- Support preparation of Ethics Committee and Regulatory Authority submissions, as applicable.
- Assist with the coordination of clinical supplies, laboratory kits and other study materials.
- Participate in study team and vendor meetings and ensure appropriate follow-up of decisions and action items. Site Management & Monitoring
- Serve as an operational point of contact for assigned investigational sites.
- Develop and maintain effective working relationships with investigators, study coordinators and other site personnel.
- Conduct site feasibility and qualification activities.
- Conduct or support Site Initiation Visits, Monitoring Visits and Close-Out Visits, depending on experience and study requirements.
- Perform remote and on-site monitoring activities in accordance with the study monitoring plan.
- Review CRF/eCRF data and follow up with sites on outstanding queries and documentation.
- Review source documentation and clinical data to ensure protocol compliance, data quality and patient safety.
- Review informed consent documentation, protocol deviations, adverse event reporting and other key study documentation.
- Prepare monitoring visit reports and follow-up communications within required timelines.
- Identify site performance, quality or compliance issues and ensure timely follow-up and escalation to the Director of Clinical Operations. Quality & Compliance
- Ensure clinical activities are conducted in accordance with the protocol, ICH-GCP, applicable regulatory requirements and company procedures.
- Maintain clinical documentation in an accurate, complete and inspection-ready state.
- Contribute to ongoing TMF quality control and study-level quality reviews.
- Support preparation for audits and regulatory inspections.
- Identify potential quality or compliance risks and escalate them appropriately.
- Contribute to the development and continuous improvement of clinical procedures, templates, trackers and working practices appropriate for a growing biotech organization. Candidate profileEducation & Experience
- Bachelor’s or Master’s degree in Life Sciences, Biomedical Sciences, Pharmacy, Nursing, Clinical Research or a related discipline.
- Approximately 2–3 years of relevant professional experience in clinical research, ideally within a biotech, pharmaceutical company or CRO.
- Previous experience as a CTA, Junior CRA, CRA or Clinical Research Coordinator.
- Practical experience with clinical trial documentation, site management and/or monitoring activities.
- Good understanding of ICH-GCP and clinical trial processes.
- Experience with TMF/eTMF, EDC and other clinical trial systems is desirable.
- A valid driving license is required, as the position involves travel to investigational sites and other study-related locations. Personal Skills & Competencies The successful candidate should demonstrate:
- A hands-on and proactive approach.
- Strong organizational skills and attention to detail.
- Ability to manage multiple priorities and follow activities through to completion.
- Ability to work autonomously while knowing when to seek guidance or escalate an issue.
- Strong interpersonal skills and confidence interacting with investigators, CROs, vendors and consultants.
- Flexibility and willingness to contribute beyond a narrowly defined

job description
when required.
- A pragmatic and solution-oriented mindset.
- Curiosity and willingness to learn about different aspects of clinical development.
- Strong written and verbal communication skills in English; additional European languages are an asset. Travel Regular travel to investigational sites and occasional travel for investigator meetings, vendor meetings or other clinical activities should be expected (mainly in Belgium, sometimes in France). OfferThis position provides an opportunity to work close to the decision-making process of a clinical-stage biotech company and to gain broader exposure than would typically be possible in a larger organization. Working directly with the Director of Clinical Operations and interacting with senior management, scientists, clinical investigators and specialized external partners, the CRA–CTA will progressively develop experience across clinical trial execution, site management, monitoring and outsourced clinical operations. The role is intended to evolve with the company and its clinical development programs, providing opportunities to take increasing ownership of clinical activities and develop toward a more autonomous CRA / Clinical Operations position.

We offer
a competitive salary and benefits package, tailored to the candidate’s experience and responsibilities, which may include:
- Competitive gross salary.
- Company car, where appropriate depending on the role and travel requirements.
- Comprehensive hospitalization and group insurance / pension plan.
- Meal vouchers.
- Flexible working arrangements, including the possibility to work from home / telework when compatible with study activities and business needs.
- Company mobile phone and subscription.
- Company laptop and required IT equipment.
- Access to professional training and development opportunities, based on the candidate’s experience and the evolving needs of the position. Beyond the compensation package, the position offers the opportunity to join a small, agile and growing biotech company, with direct exposure to key clinical development activities, close interaction with senior management and significant opportunities for professional growth. For more information and applications, please contact wendy.sonnet@inhatarget.com