Senior Clinical Research Associate

RBW Consulting; Netherlands; On-site; EUR 55,000 - 75,000; Full time

Job summary

RBW Consulting is seeking an experienced Clinical Research Associate to support EU-wide studies from Phase I to IV. You will oversee site progress, ensure GCP/ICH compliance, and collaborate closely with the Clinical Trial Manager. Travel to Netherlands sites will be required, with on-site monitoring at the core of this role.

The position offers a permanent role within a large monitoring function, with opportunities to mentor junior CRAs and develop expertise across therapeutic areas.

Qualifications

• Minimum 1–2 years on-site monitoring experience in clinical trials.
• Strong understanding of the clinical research process and terminology.
• Excellent written and verbal communication skills.
• Proficient in Dutch and English.
• Ability to build productive relationships with investigators and study staff.
• Ability to manage multiple priorities in a matrix environment.
• Knowledge of GCP/ICH guidelines.

Responsibilities

• Conduct site qualification visits and monitor progress against protocol.
• Coordinate site initiation activities and regulatory readiness.
• Lead initiation visits and train site staff on eCRF and EDC usage.
• Perform routine monitoring and close-out visits with adherence to GCP.
• Prepare clear monitoring reports and follow-up letters.
• Manage trial material accountability and inventories as required.
• Review data quality through source data verification and SI/OQ checks.
• Serve as primary contact between the sponsor and investigators.
• Assist with protocol and study documentation reviews as needed.
• Provide field training and mentor junior CRAs.

Skills

On-site monitoring

GCP/ICH knowledge

Communication skills

Dutch and English

Relationship building

Independent work

Tools

eCRF

EDC systems

Job description

Are you an experienced Clinical Research Associate who enjoys working closely with sites and contributing to studies that address areas of unmet medical need? This is a permanent opportunity to join our client’s EU Clinical Monitoring team, supporting Phase I–IV studies and playing a key role in high-impact clinical trials across a range of therapeutic areas.

About Our Client

Our client is a well-established clinical research organisation partnering with biotech and pharma companies. They focus on innovative therapies where there is genuine unmet medical need and offer their team a fast-paced, collaborative environment. You will join a large, supportive clinical monitoring department that provides structure, clear processes and the chance to learn from experienced clinical leaders while contributing to global studies.

What’s In It For You?

In this role you will have the autonomy to manage your own sites while benefiting from strong operational support and defined study processes. You will be trusted to make decisions at site level, build long-term relationships with investigators and see the full lifecycle of studies from start-up through to close-out. Working within a large monitoring function also means clear opportunities to grow your skills, take on more complex trials and support junior CRAs as a mentor in the field.

The Role

As Clinical Research Associate, you will oversee the progress of clinical investigations across Phase I–IV trials, ensuring high-quality data and site compliance with Good Clinical Practice and study procedures. You will work closely with the Clinical Trial Manager and/or Lead CRA, acting as the primary contact for your sites and helping keep studies on track against agreed timelines.

Key Responsibilities

• Participate in investigator recruitment, conducting site evaluation visits to assess site capability to manage and conduct the clinical study.
• Coordinate site and internal activities in preparation for study initiation, ensuring all operational requirements are in place.
• Lead study initiation visits, reviewing protocols, regulatory aspects and study procedures with site personnel and providing training on eCRF completion and EDC systems.
• Conduct routine monitoring and close-out visits, ensuring adherence to Good Clinical Practices, investigator integrity and site compliance with study procedures.
• Perform validation of source documentation and prepare clear, timely monitoring reports and follow-up letters in line with SOPs.
• Document accountability, stability and storage conditions of clinical trial materials and perform investigational product inventories as required.
• Review the quality and integrity of clinical data through in-house review of electronic CRFs and on-site source data verification, resolving data queries with the site.
• Serve as the primary contact between our client and investigators, managing correspondence and supporting timely transmission of clinical data.
• Contribute to the review of protocols, eCRFs, study manuals and other trial documentation when requested by the Clinical Trial Manager and/or Lead CRA.
• Assist with and attend Investigator Meetings and study-related, company, departmental and external meetings as needed.
• Ensure all study deliverables are completed in line with agreed study timelines.
• Conduct field evaluation visits and provide field training to more junior CRAs, acting as a mentor to colleagues new to the company or study.

About You

You are a proactive CRA who enjoys both the scientific and operational aspects of clinical research. You are confident managing multiple priorities, communicating with investigators and working both independently and as part of a matrix team.

Skills and Experience

• Strong understanding of the clinical research process and working knowledge of functional areas involved in clinical trials, including relevant medical terminology.
• Minimum of 1–2 years’ on-site monitoring experience within clinical trials.
• Excellent written and verbal communication skills, able to explain complex concepts clearly to study personnel.
• Ability to develop productive professional relationships internally and with healthcare professionals at research and clinical institutions.
• Proven ability to handle several priorities across multiple, complex trials.
• Ability to reason independently and recommend appropriate solutions to issues arising at sites.
• Comfortable working independently while contributing effectively within a matrix team environment.
• Sound knowledge of current GCP/ICH guidelines and their application to clinical research.
• Strong communication skills in Dutch and English are essential.

Location Requirement

For this position you must be based in the Netherlands and able to travel to sites as required.