Clinical Research Associate

This is a fully remote position, open to applicants in Kentucky, +1 more state.

📋 Description

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

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

• Conduct Site Qualification Visits to evaluate site eligibility.

• Establish and nurture relationships with site personnel to streamline the onboarding process.

• Ensure all activities adhere to ICH-GCP, local regulations, and internal Standard Operating Procedures (SOPs).

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

• Act as the primary contact for sites, study teams, and external stakeholders throughout the start-up phase.

• Manage investigator contracts, regulatory paperwork, and site-specific start-up tasks.

• Provide project status updates in line with milestones.

• Monitor, report, and analyze Key Performance Indicators (KPIs) related to site selection and start-up timelines.

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

• Maintain precise documentation to ensure readiness for inspections.

• Support sites through the activation process until they achieve Green Light status.

• Coordinate the completion of pre-study requirements, including contracts, budgets, and vital documentation.

• Assist in preparations for audits and inspections.

⛳️ Requirements

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

• Preferred location is Nashville, TN, or near a major airport; the TN/KY region close to a major hub is acceptable.

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

• A minimum of 1–3 years of experience in monitoring clinical trials across various therapeutic areas.

• Experience in analytical/risk-based monitoring is advantageous.

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

• Capacity to work closely with investigators and site personnel to adhere to study timelines.

• Proficient in utilizing CTMS, EDC, eTMF, dashboards/metrics, IWRS, and safety reporting systems.

• Excellent communication and influencing skills to effectively manage study sites both remotely and in-person.

• A strong team player and self-starter capable of working 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.