Clinical Research Associate – Start up

This is a fully remote position, open to applicants in Arizona, +4 more states.

📋 Description

• Engage in various clinical trials spanning multiple therapeutic areas with a focus on start-up activities.

• Collaborate with local operations teams to identify, select, and activate clinical trial sites.

• Conduct Site Qualification Visits to evaluate site eligibility.

• Foster relationships with site personnel to support onboarding processes.

• Ensure all activities adhere to ICH-GCP, local regulations, and internal SOPs.

• Coordinate the collection of regulatory approvals, contracts, budgets, and essential documentation.

• Serve as the primary point of contact for sites, study teams, and external stakeholders during the start-up phase.

• Manage investigator contracts, regulatory documents, and site-specific start-up initiatives.

• Provide updates on the status of project milestones.

• Monitor, report, and analyze KPIs related to site selection and start-up timelines.

• Identify and resolve issues that may hinder study initiation or impact deliverables.

• Maintain accurate documentation to ensure inspection readiness.

• Support sites throughout the activation process until achieving Green Light status.

• Assist with preparations for audits and inspections.

⛳️ Requirements

• A minimum of a B.S., R.N., or equivalent degree, ideally in Biological Sciences.

• Must be located in the western region, preferably near a major airport.

• 2–3 years of experience in monitoring clinical trials within the pharmaceutical industry.

• 1–3 years of experience in monitoring cross-therapeutic area clinical trials.

• Knowledge across multiple therapeutic areas is essential.

• Experience in study start-up as a Clinical Research Associate (CRA).

• Analytical or risk-based monitoring experience is advantageous.

• Proven ability to actively drive patient recruitment strategies at designated sites.

• Capability to work closely with investigators and site staff to meet study timelines.

• Proficiency in operating systems and databases such as CTMS, EDC, eTMF, dashboards/metrics, IWRS, and safety reporting systems.

• Excellent communication and influencing skills for managing study sites both remotely and in person.

• Strong team player and self-motivated individual with the ability to work independently.

• Comprehensive understanding of Good Clinical Practice, ICH guidelines, and local regulatory standards.

• Legally authorized to work in the United States.

• Must not require current or future sponsorship for employment visa status.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Reasonable accommodations available during the recruitment process.