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Cra Ii- Immunology/ Rheumatology (Kansas, Missouri, Indiana Or Ohio)

Syneos Health
Syneos Health
2+ years
Not Disclosed
10 Dec. 18, 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

Job Title: Clinical Research Associate II - Immunology/Rheumatology
Location: Home-Based (Kansas, Missouri, Indiana, or Ohio)
Job ID: 24006849
Closing Date: Ongoing

Job Description:

Syneos Health is seeking a Clinical Research Associate II (CRA II) with experience in Immunology/Rheumatology to join our team. This position is home-based in Kansas, Missouri, Indiana, or Ohio and will be responsible for managing site qualification, initiation, monitoring, and close-out visits for clinical trials. You will ensure protocol compliance, maintain regulatory standards, and assess site performance to support the delivery of clinical projects. As a CRA II, you'll play a key role in improving clinical research processes and ensuring data integrity.

Key Responsibilities:

  • Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) in line with ICH-GCP and protocol compliance.
  • Ensure informed consent is obtained and documented correctly for each subject/patient.
  • Perform Source Document Review and verify data accuracy and completeness in case report forms (CRFs).
  • Manage investigational product (IP) inventory and ensure proper handling and storage according to protocol.
  • Review and ensure accuracy of the Investigator Site File (ISF) and reconcile it with the Trial Master File (TMF).
  • Support site recruitment, retention, and awareness strategies.
  • Participate in clinical training, meetings, and audits to ensure compliance with clinical standards.
  • Collaborate with site staff and central monitoring teams to ensure compliance with project timelines.

Qualifications:

  • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
  • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
  • Strong communication and organizational skills.
  • Willingness to travel up to 75% of the time.
  • Experience in Immunology/Rheumatology clinical research is preferred.