Experienced Cra Denmark

5+ years

Not Disclosed

Remote - Europe

10 Sept. 7, 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

Clinical Research Associate

Location: Denmark (Office-based / Hybrid / Remote)

About Syneos Health:

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization, dedicated to accelerating customer success. Our approach integrates unique clinical, medical affairs, and commercial insights to address modern market challenges. Our Clinical Development model places customers and patients at the heart of everything we do. We continually seek ways to streamline our processes, making Syneos Health not only easier to work with but also a great place to work.

Join our global team of over 29,000 employees across 110 countries and discover why working at Syneos Health truly matters everywhere.

Why Syneos Health?

We are committed to developing our people through career progression, technical and therapeutic area training, and a robust total rewards program.
Our Total Self culture fosters an environment where everyone can be their authentic selves, and we’re dedicated to supporting our people.
We strive to create an inclusive workplace that values diverse perspectives and experiences, building a company where everyone feels they belong.

Job Responsibilities:

Conduct site qualification, initiation, interim monitoring, site management, and close-out visits, either on-site or remotely, ensuring compliance with regulatory standards, ICH-GCP, and/or Good Pharmacoepidemiology Practices (GPP).
Evaluate site performance and staff, providing recommendations and action plans for site-specific issues. Communicate serious issues to the project team promptly.
Ensure informed consent is properly obtained and documented for each subject. Maintain confidentiality and assess factors affecting subject safety and clinical data integrity.
Review site processes, source documents, and medical records to verify accuracy and completeness of clinical data. Address query resolution and guide site staff as needed.
Verify compliance with electronic data capture requirements and perform investigational product (IP) inventory, reconciliation, and review.
Regularly review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF), ensuring adherence to local guidelines for document archiving.
Document activities through confirmation letters, follow-up letters, trip reports, and communication logs. Support subject recruitment, retention, and awareness strategies.
Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met. Adapt to changing priorities effectively.
Act as a primary liaison with study site personnel or collaborate with Central Monitoring Associates. Ensure compliance and training for site and project-specific team members.
Attend and prepare for Investigator Meetings and sponsor face-to-face meetings. Participate in global clinical monitoring/project staff meetings and clinical training sessions.
Provide guidance on audit readiness and support audit preparation and follow-up actions. May supervise, train, or mentor junior CRAs.

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 other applicable regulatory requirements.
Previous monitoring experience in Denmark is required.
Proficiency in computer skills and the ability to adapt to new technologies.
Excellent communication, presentation, and interpersonal skills. Moderate critical thinking skills expected.
Fluency in Danish and proficiency in English.
Ability to travel regularly throughout Denmark and occasionally to the wider Nordics region.

Get to Know Syneos Health:

Over the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites with 675,000+ trial patients. At Syneos Health, we encourage initiative and innovation in a dynamic and competitive environment. Learn more about us and explore opportunities at Syneos Health.

Additional Information:

The tasks and responsibilities listed are not exhaustive and may be adjusted as needed. Syneos Health is committed to complying with all relevant employment legislation, including providing reasonable accommodations under the Americans with Disabilities Act.

Apply for This Job:

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At Syneos Health, we value diversity and encourage all qualified individuals to apply, even if their experience doesn’t perfectly match the job description. We also welcome transferable skills and invite you to explore opportunities with us.

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