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Sr Cra I (Sponsor Dedicated) Sweden

2+ years
Not Disclosed
10 Dec. 5, 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

This job description outlines the role of Senior Clinical Research Associate I at Syneos Health, focusing on clinical site monitoring, compliance, and patient safety in biopharmaceutical studies. Below is a summary of key elements:


About Syneos Health

Syneos Health is a global leader in biopharmaceutical solutions, offering integrated services in clinical development, medical affairs, and commercialization. The company is committed to innovation, diversity, and fostering a collaborative, inclusive workplace.


Role Overview

The Senior Clinical Research Associate I will oversee clinical site management activities such as qualification, initiation, monitoring, and closure visits. Responsibilities include ensuring compliance with GCP/ICH guidelines, managing investigational product (IP) logistics, and maintaining accurate documentation. This role requires expertise in patient safety, data accuracy, and fostering positive site relationships.


Key Responsibilities

  • Clinical Monitoring: Conducts site visits to assess compliance, verify informed consent, review source documents, and resolve queries.
  • Regulatory Compliance: Ensures adherence to GCP/ICH guidelines, protocol requirements, and sponsor SOPs.
  • Data Integrity: Reviews and reconciles source data, Investigator Site Files (ISFs), and Trial Master Files (TMFs).
  • Investigational Product (IP) Oversight: Manages inventory, storage, security, and administration according to protocols.
  • Communication: Documents activities in reports and engages with investigators, sponsors, and regulatory bodies as required.
  • Support for Real-World Late Phase (RWLP) Studies: Engages with country teams, regulatory experts, and medical staff for local trial execution.

Qualifications

  • Education: Bachelor’s degree or equivalent in a related field; nursing credentials (RN) also considered.
  • Experience: Knowledge of GCP/ICH guidelines, clinical monitoring, and site management.
  • Skills: Proficiency with digital tools, strong interpersonal skills, and critical thinking abilities.
  • Travel Requirement: Up to 75% travel for site visits and study-related tasks.

Why Join Syneos Health?

  • Career Development: Comprehensive training, mentorship, and growth opportunities.
  • Inclusive Culture: A commitment to diversity and fostering a supportive environment where employees can thrive.
  • Industry Impact: Collaboration with leading pharmaceutical organizations to advance therapeutic innovations.

Additional Notes

  • The role may include responsibilities outside the job description as needed, and the company offers accommodations under ADA guidelines.

For further details about Syneos Health and its culture, visit their career page or reach out for additional information.