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Cra Ii / Sr Cra - Phase I-Iii Single Sponsor ** Denmark **

2+ years
Not Disclosed
10 April 25, 2025
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

 

 


Job Title: Clinical Research Associate II / Sr CRA – Phase I-III (Single Sponsor)

Location: Denmark – Home-Based

Job Type: Full-time

Job ID: 25003356

 


Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions company, driving innovation across clinical development, medical affairs, and commercial solutions. With a global footprint of 29,000 employees in over 110 countries, Syneos Health is dedicated to accelerating the delivery of therapies through a collaborative and patient-centric approach.

 


Job Description:

The CRA II / Sr CRA will be dedicated to a single sponsor, responsible for overseeing Phase I-III clinical trials in a home-based setup within Denmark. The role includes site management, regulatory compliance, patient safety assurance, and continuous engagement with site teams to ensure high-quality clinical research execution.

 


Key Responsibilities:

 

  • Perform all phases of site management activities including qualification, initiation, monitoring, and close-out visits.

  • Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol guidelines.

  • Review informed consent processes, assess subject safety and clinical data integrity.

  • Conduct source document reviews, verify CRF data, and resolve queries within timelines.

  • Support investigational product inventory, reconciliation, and ensure proper storage and administration.

  • Maintain and reconcile the Investigator Site File (ISF) and Trial Master File (TMF).

  • Document site activities through reports, logs, and correspondence in compliance with SOPs.

  • Provide ongoing training and ensure audit readiness at site level.

  • Act as primary liaison for site personnel, ensuring adherence to study protocols and project timelines.

  • Contribute to recruitment and retention strategies, and attend sponsor and investigator meetings as required.

  • For Real World Late Phase projects: support site lifecycle management, chart abstraction, collaborate with stakeholders, and suggest new sites.

 


Qualifications:

 

  • Bachelor’s degree or RN in a related field, or an equivalent mix of education and experience.

  • In-depth knowledge of GCP/ICH Guidelines and regulatory frameworks.

  • Strong computer proficiency and adaptability to new technologies.

  • Excellent communication, presentation, and interpersonal skills.

  • Willingness to travel regularly up to 75%.