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!*clinical research associate (cra) - belgium- top cro globally!*

Louvain
CDI
Planet Pharma
Publiée le 9 mars
Description de l'offre

!*Clinical Research Associate (CRA) - Belgium- Top CRO globally!*

Location: Remote in Belgium

Start date: ASAP

Shift Pattern: No

Work Arrangement: Remote based with 6-8 visits per month

Type of position: Permanent

Job Description

Planet Pharma are working with a global, biomarker‐driven Contract Research Organization (CRO) that supports pharmaceutical and biotech companies in developing new therapies. They combine laboratory services, clinical trial execution, and data science to accelerate drug development.

They operate across the full clinical development lifecycle, offering:

* Clinical trial management — running global studies, especially complex oncology and rare‐disease trials.
* Advanced laboratory services — biomarker testing, specialty assays, and sample analysis.
* Data intelligence — integrating biological, clinical, and operational data to optimise trials.
* Regulatory and scientific expertise — supporting submissions and study design.

Description:

We are seeking a motivated Clinical Research Associate (CRA) to join our growing clinical operations team. This role goes beyond traditional monitoring and offers full protocol ownership, involvement across the study lifecycle, and genuine long‐term career development. CRAs typically manage one protocol at a time and are empowered to take full responsibility for study delivery, from start‐up through close‐out.

This position can be office‐based or home‐based, with approximately 6–8 monitoring visits per month, depending on study needs.

Key Responsibilities

Study Start‐Up (SSU)

* Lead and support study start‐up activities, including ethics submissions, regulatory documentation, and site activation.
* Participate in contract and budget negotiations with sites.
* Ensure all essential documents are collected, reviewed, and filed in accordance with ICH‐GCP and SOPs.

Monitoring

* Conduct routine monitoring visits, including site initiation, interim monitoring, and close‐out visits.
* Verify source data, ensure protocol compliance, and oversee investigational product accountability.
* Identify, document, and resolve site issues, deviations, and data queries.
* Build strong relationships with site staff to support high‐quality study conduct.

Study Management & Oversight

* Take full ownership of assigned protocols, ensuring timelines, quality standards, and deliverables are met.
* Collaborate closely with cross‐functional teams including regulatory, data management, and project leadership.
* Maintain accurate study documentation and contribute to TMF completeness.
* Support risk‐based monitoring strategies and continuous improvement initiatives.

Close‐Out

* Perform site close‐out activities, ensuring all data, documents, and regulatory requirements are complete.
* Support final study reporting and audit readiness.

Requirements

* Previous experience as a CRA with exposure to SSU, monitoring, and close‐out activities.
* Strong understanding of ICH‐GCP, clinical trial processes, and site management.
* Ability to manage workload independently while collaborating effectively with project teams.
* Excellent communication, organisation, and problem‐solving skills.
* Willingness to travel for monitoring visits (approx. 6–8 per month).

If this role isn't suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency.

We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

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