Cra België - Single Sponsor

2+ years

Not Disclosed

Remote, USA

10 Oct. 16, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Research Associate - Belgium

Job Description:

We are currently seeking an experienced Clinical Research Associate for one of our FSP clients in Belgium. At Syneos Health®, a leading integrated biopharmaceutical solutions organization, we are dedicated to accelerating customer success by translating unique clinical, medical affairs, and commercial insights into impactful outcomes.

Our Clinical Development model places the customer and the patient at the center of everything we do. We continually strive to simplify and streamline our processes to enhance collaboration and drive results.

Why Syneos Health?

We are passionate about developing our people through career progression, supportive management, technical training, and a comprehensive rewards program. Our commitment to a Total Self culture fosters an inclusive environment where everyone can thrive.

Job Responsibilities:

Conduct site qualification, initiation, monitoring, management, and close-out visits, ensuring compliance with regulatory and ICH-GCP guidelines.
Evaluate site performance and communicate serious issues to the project team, developing appropriate action plans.
Verify informed consent processes, protecting patient confidentiality and assessing safety and data integrity at sites.
Assess site processes and conduct source document reviews to ensure data accuracy.
Resolve queries effectively and support site staff in achieving timely resolutions.
Ensure compliance with electronic data capture and manage investigational product inventory.
Maintain accurate documentation of activities, supporting patient recruitment and retention strategies.
Manage project scope, budgets, and timelines at the site level, adapting to changing priorities.
Act as a liaison with site personnel, ensuring compliance and providing necessary training.
Prepare for and attend Investigator Meetings, contributing to audit readiness standards.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent experience.
Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
Previous monitoring experience in oncology.
Proficiency in computer skills and adaptability to new technologies.
Fluency in French and Dutch.
Strong communication and interpersonal skills.
Willingness to travel throughout Belgium.

Get to Know Syneos Health:

Over the past five years, we have worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, contributing to over 200 studies across 73,000 sites and 675,000+ trial patients.

Join us in challenging the status quo and driving innovation in a competitive, ever-changing environment.

Additional Information:

This job description is not exhaustive. The Company may assign additional tasks and responsibilities as necessary. Syneos Health is committed to building a diverse and inclusive workplace and encourages applicants with transferable skills to apply.

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