Senior Clinical Research Associate (CRA) - Belgium
Syneos Health is a leading biopharmaceutical solutions organization, dedicated to accelerating customer success by translating clinical, medical, and commercial insights into outcomes. We are seeking an experienced Senior Clinical Research Associate to join our Belgian team. This is a fantastic opportunity to work in a collaborative, innovative environment and contribute to advancing clinical development efforts.
Why Syneos Health
At Syneos Health, we’re passionate about developing our people. We offer career development, peer recognition, and a supportive environment where you can be your authentic self. Our Total Self culture fosters diversity of thought, backgrounds, and experiences, creating a place where everyone feels they belong.
We are continuously evolving the company we want to work for, and our customers want to collaborate with. We’re driven to make a meaningful impact by accelerating the delivery of life-changing therapies.
Job Responsibilities
Site Monitoring: Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP, and study protocols.
Informed Consent & Data Integrity: Ensure proper informed consent is obtained and documented. Assess safety and clinical data integrity by reviewing site processes, documents, and medical records.
Clinical Data Management: Verify clinical data entered in the case report form (CRF) for accuracy and completeness. Resolve queries remotely and on-site, ensuring closure within agreed timelines.
Investigational Product (IP) Management: Ensure correct handling, dispensing, storage, and compliance with IP protocols. Perform inventory and reconciliation as needed.
Regulatory Compliance: Maintain accurate Investigator Site Files (ISF) and reconcile them with the Trial Master File (TMF). Ensure archiving of essential documents according to local regulations.
Training & Communication: Provide guidance and training to site personnel. Act as a liaison between site staff and the study team to ensure compliance and effective communication.
Project Management: Manage site-level activities, ensuring project timelines and objectives are met. Adapt to changing priorities to achieve project goals.
Audit Readiness: Ensure site compliance with audit standards and prepare for audits, providing necessary follow-up actions.
Mentorship: Offer training and mentorship to junior CRAs and may be involved in training sign-offs for new staff.
Qualifications
Education: Bachelor’s degree in a related field (or equivalent combination of education and experience).
Experience: Previous monitoring experience in Belgium, with specific expertise in rare diseases and/or immuno-neuropathy preferred.
Skills: Proficiency in computer systems and new technologies, with strong communication, presentation, and interpersonal skills. Critical thinking skills are expected.
Languages: Fluency in Dutch, French, and English is required.
Travel: Must be able to travel for monitoring visits throughout Belgium.
Regulatory Knowledge: Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
About Syneos Health
In the past five years, Syneos Health has contributed to 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites with more than 675,000 trial patients. Syneos Health is committed to accelerating the delivery of therapies that change lives.
Additional Information
The tasks listed in this job description may not be exhaustive, and other duties may be assigned. The company reserves the right to modify the role based on evolving needs. Syneos Health is an equal opportunity employer and is committed to compliance with all applicable employment laws, including providing accommodations to employees with disabilities when necessary.
Ready to join a team that truly makes a difference? At Syneos Health, WORK HERE MATTERS EVERYWHERE.
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
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Netherlands |Remote Australia :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Italy |Lombardy :
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Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
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