CRA II, Onc​/Neuro​/Rare​/Derm (West Coast, Midwest, Northeast

Position Overview

Premier Research is looking for a CRA II, Onc/Neuro/Rare/Derm (West Coast, Midwest, Northeast) to join our Clinical Monitoring and Site Management team. As a Clinical Research Associate II, you will conduct all monitoring visits, manage clinical data integrity, maintain eTMF, and support study sites throughout the project lifecycle.

• Conduct monitoring visits (qualification, initiation, interim, close‑out; remote/onsite) per the Clinical Monitoring Plan, ensuring data integrity, patient safety, and timely deliverables.
• Ensure validity, correctness, and completeness of clinical data per ICH GCP/ISO
  14155, protocol, and client requirements; manage query resolution with sites and Data Management.
• Maintain TMF/eTMF per ICH GCP Appendix C and organizational filing guidelines; review site documents for accuracy and completeness; review IP accountability and logs as directed.
• Manage communication with study sites, project teams, and management; attend Investigators’ Meetings and provide required internal/study‑specific training.
• Perform administrative responsibilities such as expense submission, time/hours entry, project tracking, site visit metrics, and compliance with global and local laws.
• Proactively support the project by reducing backlog, assessing feasibility/recruitment, acting as a resource/SME for other CRAs, and taking on additional country‑ or project‑specific responsibilities as assigned.

• Undergraduate degree or its international equivalent in clinical, science, or health‑related field from an accredited institution; a licensed health‑care professional (e.g., registered nurse); or equivalent work experience.
• ≥2years of experience in clinical trials and proven success as a CRA; completion of a CRA training program.
• Strong regulatory/clinical knowledge of ICH GCP, FDA/EU/local regulations, ISO
  14155, drug/device development, and clinical monitoring procedures.
• Relevant clinical/health systems and cultural/regional knowledge for assigned markets.
• Proven leadership and collaboration abilities; experience coaching or mentoring CRAs; strong team player; full‑time availability to internal/external stakeholders; global experience preferred.
• Self‑directed, organized, excellent time‑management skills; ability to multitask and adapt in a fast‑paced, changing environment.
• Accountable and customer‑focused; dependable, decisive problem‑solver, and customer‑service oriented both internally and externally.
• Experience in Oncology, Rare Disease, Neurology, or Dermatology.

• Travel 70‑85% of the time.
• Lifting up to25lb.
• Valid driver’s license, passport as required.
• Location:
  
  West Coast, Midwest, or Northeast regions.

The annualized minimum base pay for this role is $80,000

USD. Salary will be influenced by qualifications, skills, and proficiency for the role.

Benefits may include health insurance, retirement plans, and paid time off.

The anticipated start date is September
14, 2026.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.