Home-Based Senior Cra The Netherlands

2+ years

Not Disclosed

Remote, USA

10 Dec. 10, 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

Senior Clinical Research Associate – The Netherlands
Syneos Health® – Clinical Research

About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We focus on delivering innovative clinical, medical affairs, and commercial insights that drive outcomes and address the evolving needs of the market. Join us as we work with passionate problem-solvers to deliver therapies that improve lives globally.

At Syneos Health, we believe WORK HERE MATTERS EVERYWHERE.

Role Overview
We are currently recruiting for a Senior Clinical Research Associate to join our team in The Netherlands. This role will perform site qualification, initiation, interim monitoring, site management, and close-out visits (both on-site and remotely) while ensuring compliance with ICH-GCP, regulatory requirements, and protocol. You will use your judgment and experience to evaluate the overall performance of sites and provide site-specific recommendations.

Key Responsibilities

Perform site visits, including qualification, initiation, interim monitoring, and close-out activities, ensuring ICH-GCP and regulatory compliance.
Verify informed consent processes and documentations, ensuring the confidentiality and safety of subjects/patients.
Conduct source document reviews and confirm that clinical data is accurate and complete.
Resolve data queries remotely or on-site and support site staff in data resolution.
Ensure compliance with electronic data capture requirements and investigate any issues related to investigational products (IP).
Maintain accurate records of activities in tracking systems and ensure the Investigator Site File (ISF) is complete and up to date.
Manage communication and activities to meet project timelines and objectives while adapting to changing priorities.
Act as a liaison between the project site and project team, ensuring the site and project teams are trained and compliant with requirements.
Provide mentorship and training for junior Clinical Research Associates (CRAs).
Collaborate on late-phase studies, including chart abstraction and data collection.
Identify potential study sites and assist with regulatory documentation.
Support audit readiness and participate in global clinical monitoring/project staff meetings.
Ensure compliance with local and international regulatory standards.

Qualifications

Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Strong communication and interpersonal skills, with fluency in Dutch and proficiency in English.
Excellent critical thinking skills, with the ability to manage site-related activities and address issues promptly.
Must be comfortable with required travel within The Netherlands for site visits.
Proficiency in computer skills and willingness to embrace new technologies.

Why Syneos Health?
Syneos Health is committed to developing our people, providing career progression, and a supportive work environment. We value diversity, inclusion, and creating a company culture where everyone feels they belong. Join our team and help us make a difference by delivering innovative therapies to patients around the world.

Get to Know Us
Learn more about Syneos Health and the exciting opportunities we offer by visiting our website.

Join Our Network
If this role doesn't align with your experience or goals, join our Syneos Health Network to stay connected for future opportunities.

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Home-Based Senior Cra The Netherlands

Job Description

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