Ervaren Cra - Single Sponsor

0-5 years

Not Disclosed

Remote, USA

12 June 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, 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

Position: Clinical Research Associate

Location: The Netherlands

Employment Type: Full-time

About Syneos Health: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Whether through Functional Service Provider partnerships or Full-Service environments, Syneos Health collaborates with passionate problem solvers to innovate and accelerate the delivery of therapies, ultimately changing lives.

Why Syneos Health:

Commitment to developing employees through career progression, supportive management, and comprehensive training programs.
Total Self culture promoting authenticity and inclusivity, where diversity of thought and perspectives are valued.
Continuous improvement to create a workplace where everyone feels they belong and can contribute meaningfully.

Responsibilities:

Conducts site qualification, initiation, monitoring, and close-out visits to ensure regulatory and protocol compliance.
Evaluates site performance and provides recommendations for site-specific actions, escalating serious issues to the project team.
Verifies informed consent process and protects subject/patient confidentiality.
Conducts source document review and ensures accuracy and completeness of clinical data.
Resolves queries and provides guidance to site staff, driving resolution within agreed timelines.
Ensures compliance with electronic data capture requirements and performs investigational product inventory.
Maintains accuracy and completeness of Investigator Site File and Trial Master File.
Documents activities and supports subject/patient recruitment, retention, and awareness strategies.
Manages site-level activities to ensure project objectives, deliverables, and timelines are met.
Acts as a primary liaison with study site personnel and participates in clinical training sessions.
Provides guidance on audit readiness standards and supports audit preparation and follow-up actions.

Qualifications:

Bachelor’s degree or RN in a related field or equivalent experience.
Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
Previous monitoring experience in The Netherlands.
Proficiency in computer skills and willingness to embrace new technologies.
Excellent communication and interpersonal skills, fluent in English and Dutch.
Ability to travel for monitoring visits.

Additional Information: Tasks, duties, and responsibilities may vary. The Company may assign other tasks as needed. Equivalent experience, skills, and education will be considered. The Company is committed to compliance with relevant legislation and providing reasonable accommodations when appropriate.

Apply for this Job: [Apply Here]

Not ready to apply? Join our Talent Network

At Syneos Health, diversity and inclusion are core values. Candidates are encouraged to apply even if their past experience does not align perfectly, as transferrable skills are considered. Join our Talent Network for additional career opportunities.

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Ervaren Cra - Single Sponsor

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