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About the Role

Premier Research is seeking a CRA II to join our Clinical Monitoring and Site Management team, contributing to the transformation of life-changing ideas into new medicines, devices, and diagnostics. Your role is essential in delivering medical innovation for patients, with opportunities for growth, skill development, and work-life balance.

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.
• Plans and prioritizes 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.
• Reviews site documents for accuracy and completeness.
• Reviews IP accountability and logs as directed.
• Manages communication with study sites, project teams, and management.
• Facilitates Investigators' Meetings and required internal/study-specific training.
• Supports 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.
• Performs other duties as assigned.

Requirements

• Undergraduate degree or its international equivalent in a clinical, science, or health-related field from an accredited institution, or a licensed health-care professional, or equivalent work experience.
• 2+ years’ experience in clinical trials.
• Proven previous 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.
• 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.
• Experience required in Oncology, Rare Disease, Neurology, or Dermatology.
• Must be located in one of the following regions: West Coast, Midwest, Northeast.

Skills

• Clinical monitoring
• Data integrity
• Patient safety
• ICH GCP
• ISO14155
• TMF/eTMF management
• Communication
• Time management
• Problem-solving
• Customer service

Location

• West Coast
• Midwest
• Northeast

Work Type

• Remote
• Onsite
• Hybrid

Experience Level

• CRA II
• 2+ years experience

Education Level

• Undergraduate degree in clinical, science, or health-related field
• Licensed health-care professional
• Equivalent work experience

Salary/Compensations

• $75,000 USD (minimum base pay)

Benefits

• Health insurance
• Retirement plans
• Paid time off

About the Company

• Premier Research is a global clinical research, product development, and consulting company dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas into new medical treatments.
• The team is inspired by a common purpose to improve patient lives.
• Premier Research is a community furthering research for patients in critical need.
• It is a diverse staff that thinks creatively, challenges ideas, and solves complex problems.
• Values include: Aim High, Work Together, Stay Agile, Get It Done, Care.
• Team members have the power to make an impact.
• Dedicated to biotech and specialty pharma.
• Provides staff with innovative technologies and continuous learning.

Equal Opportunity

• 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.