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

About the role

Premier Research is seeking a CRA II, Onc/Neuro/Rare/Derm (West Coast, Midwest, Northeast) to join our Clinical Monitoring and Site Management team. This role involves helping biotech, medtech, and specialty pharma companies bring life-changing innovations to market.

Responsibilities

• Conducts all monitoring visit types (qualification, initiation, interim, close-out; remote/onsite) per the Clinical Monitoring Plan, ensuring data integrity, patient safety, and quality/timeliness of deliverables and reports, while planning and prioritizing day-to-day site activities
• Ensures validity, correctness, and completeness of clinical data per ICH GCP/ISO14155, protocol, and client requirements; manages query resolution with sites and Data Management
• 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
• Manages communication with study sites, project teams, and management, including Investigators' Meetings and required internal/study-specific training and therapeutic knowledge-building
• Handles administrative responsibilities: timely expense submission, time/hours entry, project tracking, site visit metrics, and confidentiality/compliance with global and local laws
• 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

Requirements

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• 2+ years’ experience in clinical trials and proven previous success as a CRA required, completion of CRA training program
• Strong regulatory/clinical knowledge: 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
• Proven leadership and collaboration: experience coaching/mentoring CRAs, strong team player, full-time availability to internal/external stakeholders, and global experience preferred
• Self-directed and organized: excellent time-management skills, self-starter with sound judgment, able to multitask and adapt in a fast-paced, changing environment
• Accountable and customer-focused: dependable with strong commitment, applies consistent performance standards, decisive problem-solver, and customer-service oriented internally and externally
• Travel: 70-85%
• Lifting up to 25lbs
• Valid driver’s license, passport as required

Skills

• Experience in Oncology, Rare Disease, Neurology, or Dermatology

Benefits

Comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Pay

The annualized minimum base pay for this role is $75,000 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.

Schedule

Full-time availability to internal/external stakeholders, and global experience preferred.