Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Engage in various trials across diverse therapeutic areas with a focus on start-up operations.

• Collaborate with country operations teams to identify, select, and activate clinical trial sites in alignment with timelines and requirements.

• Conduct Site Qualification Visits to evaluate site eligibility.

• Cultivate relationships with site personnel to streamline the onboarding process.

• Ensure adherence to ICH-GCP guidelines, local regulatory standards, and internal SOPs.

• Coordinate the collection of regulatory approvals, contracts, and essential documents necessary for site activation.

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

• Oversee investigator contracts, regulatory documents, and site-specific start-up tasks.

• Provide regular status updates on 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 trial outcomes.

• Maintain accurate documentation to ensure inspection readiness.

• Support sites through the activation process until achieving “Green Light” status.

• Coordinate the fulfillment of pre-study requirements, including contracts, budgets, and essential documents.

• Assist with preparations for audits and inspections.

⛳️ Requirements

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

• Preferred location is near a major airport.

• Must have 2-3 years of experience in monitoring clinical trials within the pharmaceutical industry.

• Have at least 1-3 years of experience monitoring oncology clinical trials.

• Experience in study start-up is required.

• Analytical/risk-based monitoring experience is considered an advantage.

• Ability to actively drive patient recruitment strategies at assigned sites.

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

• Proficiency in operating and utilizing various systems and databases (e.g., CTMS, EDC, eTMF, dashboards/metrics, IWRS, safety reporting).

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

• A proactive team player and self-starter with the ability to work independently.

• In-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements.

• Legally authorized to work in the United States.

• Must not require, now or in the future, sponsorship for employment visa status.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.