Premier Research

Premier Research

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

United States of America · Mid · Full-time

Sponsorship not specified$70k-$85kDetected 6 days ago
GCPExcelClinical TrialsFDA RegulatoryResearchLeadershipCommunicationCollaborationMentoring

About the role

  • 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.
  • You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics.
  • This role is anticipated to start September 14, 2026.

Responsibilities

  • Maintains TMF/eTMF per ICH/GCP Appendix C and organizational filing guidelines, reviewing site documents for accuracy and completeness; reviews IP accountability and logs as directed
  • Proactively supports the project: reduces backlog, assesses feasibility/recruitment as needed, acts as a resource/SME for other CRAs, may take on additional country- or project-specific responsibilities, and performs other duties as assigned
  • Ensures validity, correctness, and completeness of clinical data per ICH GCP/ISO14155, protocol, and client requirements; manages query resolution with sites and Data Management

Requirements

  • Manages communication with study sites, project teams, and management, including Investigators' Meetings and required internal/study-specific training and therapeutic knowledge-building
  • 2+ years' experience in clinical trials and proven previous success as a CRA required, completion of CRA training program
  • Valid driver's license, passport as required
  • Experience required in Oncology, Rare Disease, Neurology, or Dermatology
  • To be considered for this position, you must be located in one of the following regions: West Coast, Midwest, Northeast.

Nice to have

  • experience coaching/mentoring CRAs, strong team player, full-time availability to internal/external stakeholders, and global experience preferred
  • Proven leadership and collaboration: experience coaching/mentoring CRAs, strong team player, full-time availability to internal/external stakeholders, and global experience preferred

Skills

  • excellent time-management skills, self-starter with sound judgment, able to multitask and adapt in a fast-paced, changing environment

Compensation

  • The annualized minimum base pay for this role is $80,000 USD.
  • The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Benefits

  • ICH/GCP, FDA/EU/local regulations, ISO14155, drug/device development, and clinical monitoring procedures, plus relevant clinical/health systems and cultural/regional knowledge for assigned markets
  • We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
  • All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status

Company info

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Equal opportunity

  • Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines.
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This listing is sourced directly from Premier Research's careers page and normalized into a canonical job model.