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Sr Cra I (Sponsor Dedicated) Denmark

2+ years
Not Disclosed
10 Dec. 4, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 I

About Syneos Health®
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization designed to accelerate customer success. By combining unique clinical, medical affairs, and commercial expertise, we address the evolving challenges of today’s healthcare markets.

Our Clinical Development approach prioritizes patients and customers at the heart of every endeavor. We are committed to simplifying and optimizing processes to make Syneos Health not only a preferred partner for our customers but also an exceptional workplace for our employees.

Whether in a Functional Service Provider partnership or Full-Service model, you’ll collaborate with a team of passionate problem-solvers, driving innovation to help our customers meet their goals. Our agility and dedication aim to speed up therapy delivery and transform lives.

Join our global community of 29,000+ employees in 110 countries:
Work Here Matters Everywhere.


Why Choose Syneos Health?

  • Career Growth: We foster professional development through opportunities for progression, technical training, and supportive management.

  • Inclusive Culture: Our Total Self culture celebrates individuality, promotes authenticity, and prioritizes employee well-being.

  • Collaborative Environment: Diversity of thought, culture, and experience drives innovation and belonging.


Job Responsibilities
As a Senior Clinical Research Associate I, you will play a key role in overseeing and managing clinical trial sites to ensure compliance, safety, and success.

  • Site Management: Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) while ensuring adherence to regulatory and protocol standards.

  • Patient Safety: Verify informed consent processes, monitor subject safety, and address protocol deviations or pharmacovigilance concerns.

  • Data Integrity: Conduct source document reviews, resolve data queries, and ensure compliance with electronic data capture protocols.

  • Product Oversight: Manage investigational product (IP) inventory, security, and dispensing, ensuring compliance with Good Clinical Practice (GCP) and local regulations.

  • Documentation: Maintain accurate records, including site reports, correspondence, and audit readiness standards.

  • Team Collaboration: Provide training, mentorship, and guidance to junior staff. Act as the primary liaison with site personnel and other project stakeholders.

  • Regulatory Compliance: Work with the regulatory team to apply and share updated guidelines.

  • Real-World Evidence (RWE) Support: Contribute to real-world late-phase studies, including chart abstraction, data collection, and informed consent development.


Qualifications

  • Bachelor’s degree or equivalent in a related field (or RN qualification).

  • Proficiency in GCP/ICH Guidelines and applicable regulatory requirements.

  • Strong computer skills with the ability to adapt to new technologies.

  • Excellent communication, critical thinking, and interpersonal skills.

  • Willingness to travel up to 75% as required.


About Syneos Health
In the past five years, Syneos Health has partnered on 94% of all FDA-approved novel drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites and 675,000+ patients.

Join us and challenge the status quo in a dynamic and competitive environment. Together, we’ll innovate and transform the future of healthcare.

Note: This job description is subject to change. Equivalent qualifications and experiences will be considered. Syneos Health is committed to compliance with all applicable laws, including providing reasonable accommodations to individuals with disabilities.