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Clinical Research Associate Ii (Nv, Or, Az)

Innovaderm Research
2-5 years
Not Disclosed
Geelong Vic, United States
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc 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

πŸ“’ Now Hiring: Clinical Research Associate II (NV, OR, AZ) - United States πŸ‡ΊπŸ‡Έ

πŸ’Ό Position: Clinical Research Associate II
🏒 Industry: CRO - Clinical Operations
πŸ“ Location: Home-based (Regional travel to research sites)
⏳ Job Type: Full-time

πŸ”Ž Job Overview

Innovaderm is seeking a Clinical Research Associate II (CRA) to monitor clinical studies, ensuring compliance with the protocol, standard operating procedures (SOPs), ICH-GCP, and regulatory requirements. This role is focused on dermatology studies and offers the opportunity to work with a mid-sized CRO, where your contributions will have a significant impact.

πŸ”‘ Key Responsibilities

1. Clinical Monitoring

  • Conduct site qualification, initiation, monitoring, and close-out visits
  • Prepare site visit reports and follow-up letters to investigators
  • Ensure study drug storage, dispensing, accountability, data collection, and regulatory documents are in compliance
  • Build relationships with investigators and site staff to achieve study objectives, including patient recruitment targets

2. Regulatory Compliance

  • Adhere to Innovaderm and sponsor SOPs, ICH/CGP guidelines, and applicable regulations
  • Perform source data verification and ensure on-site study integrity

3. Communication & Relationship Building

  • Participate in investigator meetings
  • Act as the primary point of contact for investigators and site staff

πŸ“Œ Requirements

πŸŽ“ Education:

  • B.Sc. in a relevant field (e.g., clinical research, nursing), or equivalent experience

πŸ›  Experience:

  • 2-5 years of experience in on-site clinical monitoring within the biotech, pharmaceutical, or CRO industry
  • Experience in dermatology is an asset

πŸ’» Skills:

  • Proficiency in ICH/GCP standards and applicable regulatory requirements
  • Strong verbal and written communication skills in English
  • Ability to work under pressure, prioritize assignments, and meet deadlines
  • Strong problem-solving and judgment skills
  • Excellent knowledge of Microsoft Office (Word, Excel, PowerPoint)

🎯 Perks & Benefits

✨ Permanent full-time position
✨ Benefits package
✨ 401K
✨ Ongoing learning and development
✨ Work from home with travel required

πŸ“Œ Company: Innovaderm (Specialized in Dermatology CRO Research)

πŸ“© Apply Now!