CRA II (Onc/Neuro/Rare/Derm)

TL;DR

CRA II (Onc/Neuro/Rare/Derm): Conducting clinical monitoring visits and ensuring data integrity, patient safety, and timely deliverables across qualification, initiation, interim, and close-out activities with an accent on ICH GCP/ISO14155 compliance, TMF/eTMF maintenance, and query resolution. Focus on managing site documentation quality, coordinating with study teams and investigators’ meetings, and supporting project execution while traveling 70–85%.

Company

hirify.global supports biotech, medtech, and specialty pharma teams in delivering clinical innovation that improves patient outcomes.

What you will do

• Conduct all monitoring visit types (qualification, initiation, interim, close-out), planning and prioritizing day-to-day site activities.
• Ensure clinical data validity, correctness, and completeness per ICH GCP/ISO14155, protocol, and client requirements; manage query resolution with sites and Data Management.
• Maintain TMF/eTMF per ICH/GCP Appendix C and filing guidelines; review site documents for accuracy and completeness and review IP accountability/logs as directed.
• Manage communication with study sites, project teams, and management, including investigators’ meetings and required internal/study-specific training and therapeutic knowledge-building.
• Handle administrative responsibilities (expenses, time/hours entry, project tracking, site visit metrics) and ensure confidentiality/compliance with global and local laws.
• Proactively support the project by reducing backlog, assessing feasibility/recruitment as needed, acting as a resource/SME for other CRAs, and taking on additional country- or project-specific responsibilities.

Requirements

• Location: must be located in West Coast, Midwest, or Northeast regions.
• Undergraduate degree (or international equivalent) in a clinical/science/health-related field, or licensed healthcare professional (e.g., registered nurse), or equivalent work experience.
• 2+ years’ clinical trials experience with proven success as a CRA; completion of CRA training program.
• Strong regulatory/clinical knowledge: ICH/GCP, FDA/EU/local regulations, ISO14155, drug/device development, and clinical monitoring procedures.
• Experience in Oncology, Rare Disease, Neurology, or Dermatology.
• Travel 70–85%; valid driver’s license and passport as required.

Culture & Benefits

• Annualized minimum base pay: $75,000 USD, with final compensation based on qualifications and role fit.
• Comprehensive benefits package may include health insurance, retirement plans, and paid time off.
• Support for growth and skill development with flexibility and work-life balance.
• Emphasis on data integrity, patient safety, and quality/timeliness of deliverables.

Hiring process

• Application review based on CRA II experience, regulatory knowledge, and therapeutic area experience.
• Interviews to assess clinical monitoring experience, compliance approach, and collaboration/leadership.
• Final evaluation of fit for West Coast/Midwest/Northeast location requirement and travel expectations.