Clinical Research Associate

2+ years

Not Disclosed

Remote

10 Oct. 22, 2024

Job Description

Job Type: Full Time 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

Experienced Clinical Research Associate (CRA) in The Netherlands

Syneos Health® is seeking an experienced CRA to take full accountability for end-to-end site management and operational delivery for allocated sites in The Netherlands. In this role, you will collaborate with various stakeholders to drive excellence throughout the study lifecycle—from start-up to conduct and close-out.

About Syneos Health: As a fully integrated biopharmaceutical solutions organization, we focus on accelerating customer success through innovative clinical, medical affairs, and commercial insights. Our model places both the customer and patient at the center of everything we do, enabling us to simplify and streamline our processes for enhanced collaboration.

Join our team of passionate problem solvers and contribute to delivering therapies that change lives. Discover why over 29,000 employees across 110 countries know: WORK HERE MATTERS EVERYWHERE.

Why Work with Us:

Career Development: We are committed to your growth through training, progression opportunities, and a supportive environment.
Total Self Culture: Our inclusive culture encourages you to be your authentic self.
Diversity: We value diverse thoughts, backgrounds, and perspectives, fostering a workplace where everyone feels they belong.

Key Responsibilities:

Perform site qualification, initiation, monitoring, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards and protocols.
Evaluate site performance and recommend actions as needed, escalating serious issues to the project team.
Verify informed consent processes and maintain patient confidentiality, assessing factors affecting safety and data integrity.
Conduct source document reviews and ensure clinical data accuracy in case report forms (CRFs).
Drive query resolution and verify compliance with electronic data capture requirements.
Manage investigational product (IP) inventory and verify compliance with labeling and security.
Maintain and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF).
Document activities as per SOPs and Clinical Monitoring Plans, supporting patient recruitment and retention strategies.
Act as the primary liaison with project site personnel, ensuring compliance with training requirements.
Prepare for and attend investigator meetings, participate in global monitoring meetings, and provide audit readiness guidance.
Mentor junior CRAs and take on clinical operations lead tasks under supervision.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent experience.
Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
Strong computer skills and ability to adapt to new technologies.
Fluency in Dutch and proficiency in English.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel for monitoring visits.

Get to Know Us: In the past five years, we’ve collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites with 675,000+ trial patients.

Additional Information: Tasks and responsibilities outlined are not exhaustive. Syneos Health may assign other duties at its discretion. Equivalent experience will also be considered. This posting complies with all applicable local laws and regulations, including the Americans with Disabilities Act, providing reasonable accommodations as needed.

Join Us: If you're ready to take on this exciting CRA role and make a meaningful impact in clinical research, we want to hear from you!

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Clinical Research Associate

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