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

11 Premier Research International LLC; California (MO); On-site; USD 72,000 - 88,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

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

The ideal candidate has an undergraduate degree in a health-related field, at least 2 years in clinical trials, strong regulatory knowledge, and leadership abilities.

Qualifications

• 2+ years of experience in clinical trials as a CRA.
• Completion of a CRA training program.
• Strong regulatory knowledge of ICH GCP, FDA/EU/local regulations, ISO14155, drug/device development.

Responsibilities

• Conduct monitoring visits (qualification, initiation, interim, close-out; remote/onsite) per plan.
• Ensure data validity and completeness per protocol and ICH GCP; resolve site queries.
• Maintain TMF/eTMF and review site documents for accuracy and completeness.
• Communicate with study sites and project teams; attend Investigators’ Meetings and provide training.
• Handle admin tasks: expenses, time entries, project tracking, site visit metrics.
• Support the project as SME for other CRAs and country-specific responsibilities.

Skills

CRA experience

Regulatory knowledge

Leadership

Oncology / Rare Disease knowledge

Travel readiness

Education

Undergraduate degree in clinical/science/health-related field

Job description

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.

What You’ll Be Doing

• 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/ISO14155, 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.

What We Are Searching For

• 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, ISO14155, 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 & Work Requirements

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

Compensation & Benefits

The annualized minimum base pay for this role is $80,000USD. Salary will be influenced by qualifications, skills, and proficiency for the role.

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

Additional Information

The anticipated start date is September14, 2026.

Equal Opportunity Statement

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.