Summary

An exciting opportunity has become available for a SeniorClinical Research Associate (CRA II) to join a general Biopharma-focused clinical research organization within a sponsor-dedicated (FSP) model. This role will primarily support cardiology studies, with potential exposure to oncology and other innovative therapeutic areas.

This position offers significantly more ownership than a traditional monitoring role, allowing CRAs to manage studies throughout the full clinical trial lifecycle while supporting a small number of protocols and becoming a true study expert.

Responsibilities

- Manage studies from start-up through close-out activities.
- Conduct Site Selection Visits (SSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs).
- Lead and support study start-up (SSU) activities, including site activation and regulatory documentation.
- Participate in site contract and budget negotiations.
- Ensure compliance with ICH-GCP, protocol requirements, SOPs, and applicable regulations.
- Build and maintain strong relationships with investigators and site personnel.
- Monitor site performance, patient safety, data quality, and protocol compliance.
- Coordinate study activities across sites and internal stakeholders.
- Identify and proactively mitigate study risks and operational challenges.

Requirements

- Minimum 2 years of independent onsite monitoring experience as a CRA.
- Experience within a CRO, pharmaceutical, biotech, or equivalent clinical research setting.
- Strong understanding of ICH-GCP and applicable clinical trial regulations.
- Experience conducting independent monitoring visits across the study lifecycle.
- Study start-up experience is highly desirable.
- Experience with site management and investigator relationships.
- Fluency in Dutch and English is required.
- French language skills are advantageous.




- Cardiology or cardiovascular experience is preferred; oncology experience is considered a plus.
- Strong communication, organizational, and problem-solving skills.
- Ability to work independently within a sponsor-dedicated model.

Location

- Home-based across Belgium
- Monitoring activities primarily conducted within Belgium
- Occasional support for sites in the Netherlands
- Travel expected as part of routine monitoring responsibilities

Why Consider This Opportunity?

- Sponsor-dedicated FSP model
- Full study ownership from start-up through close-out
- Typical allocation of only 2-3 protocols
- Clear career progression opportunities into CTM and Project Management positions
- Structured personal development plans for all CRAs
- Collaborative culture with strong leadership visibility
- Reasonable monitoring workload focused on quality rather than quantity

ABOUT PLANET PHARMA

Planet Pharma is an American-parented Employment Business/Agency providing global staffing services, headquartered in Chicago with an EMEA regional office in Central London. We operate compliantly in 30+ countries with a network of 2,500+ active contractors globally, alongside a strong permanent/direct hire offering.

Our specialist knowledge and close client relationships make us unique in the field. We were recently recognized by Forbes as the 17th best professional staffing firm and have won multiple awards for excellence and service delivery.

We have extensive expertise across Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions, Clinical Development, Quality, Biostatistics, and Medical Affairs/Writing.

Planet Pharma is an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of race, sex, disability, religion/belief, sexual orientation, or age.

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TO APPLY

Please click ‘Apply’ or contact: Joselyn Famanilay Del Rosario (Recruitment Sourcer - APAC) at Planet Pharma for more information:

E: [email protected]

T: +61 3 9123 6638

LinkedIn:

📌 Senior clinical research associate (España)
🏢 Planet Pharma
📍 España