Experienced Cra

2+ years

Not Disclosed

Remote, USA

10 Sept. 5, 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

Position: Clinical Research Associate

Location: Denmark

Company: Syneos Health®

About Syneos Health:

Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our approach combines clinical, medical affairs, and commercial insights to address modern market realities. We place the customer and patient at the center of everything we do, striving to simplify and streamline our operations to enhance both our working environment and our client partnerships.

Why Syneos Health?

At Syneos Health, we are committed to the development and growth of our people through career progression, supportive management, technical and therapeutic training, and a comprehensive rewards program. Our Total Self culture promotes authenticity and inclusion, ensuring that everyone feels they belong. Join us to be part of a dynamic team where diversity of thought, background, and perspective drives innovation and excellence.

Job Responsibilities:

Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits, either on-site or remotely, ensuring compliance with regulatory, ICH-GCP, and protocol standards. Evaluate site performance and provide recommendations for improvements, escalating serious issues as necessary.
Informed Consent: Ensure informed consent is properly obtained and documented, protecting patient confidentiality and assessing factors that affect patient safety and data integrity.
Documentation and Compliance: Review site processes, source documents, and case report forms (CRFs) to verify accuracy and completeness. Resolve queries and support data capture and compliance with electronic data requirements.
Investigational Product (IP) Management: Perform IP inventory and reconciliation, verify correct dispensation and administration, and ensure compliance with GCP and local regulations.
Training and Supervision: Provide training, mentorship, and supervision to junior CRAs, and support investigator meetings and audit preparations. Ensure all site and project team members are trained and compliant with requirements.
Project Management: Manage site-level activities, communication, and compliance to meet project objectives and timelines. Adapt to changing priorities and participate in global monitoring staff meetings as needed.

Qualifications:

Education: Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
Experience: Previous monitoring experience in Denmark is required, with a solid understanding of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
Skills: Strong computer skills, proficiency in Danish and English, excellent communication, presentation, and interpersonal skills. Ability to manage regular travel throughout Denmark and occasionally to other Nordic regions.
Other: Moderate critical thinking skills and the ability to embrace new technologies.

Why Work with Us?

At Syneos Health, you'll be part of a team that is passionate about making a difference. We offer a supportive and inclusive environment where your contributions truly matter. Join us to be part of a company that has worked on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites.

Interested in Applying?

If you’re excited about this role but don’t meet every qualification, we still encourage you to apply. We value diverse experiences and transferrable skills. To apply or join our Talent Network, please visit our careers page.

Additional Information:

Tasks and responsibilities are subject to change as needed. Equivalent experience and skills may be considered. Syneos Health is committed to providing a diverse, inclusive workplace and adheres to all relevant employment laws and regulations.

Apply Now or Join Our Talent Network

Explore more about Syneos Health and discover how you can make a difference with us.

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