Clinical Research Associate – Start up

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

📋 Description

• Engage in multiple clinical trials across Cross Therapeutic areas with a focus on start-up activities.

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

• Conduct Site Qualification Visits (SQVs) to evaluate the suitability of sites for participation in specific clinical studies.

• Establish strong relationships with site personnel to ensure a seamless onboarding process.

• Guarantee that all activities comply with ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).

• Coordinate with the country operations team to gather essential documents (such as regulatory approvals and contracts) to facilitate timely site activation.

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

• Collaborate closely with the country operations team to oversee investigator contracts, regulatory documents, and site-specific start-up tasks.

• Provide regular updates on status to both internal and external stakeholders, ensuring alignment with key project milestones.

• Monitor, report, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.

• Proactively identify and resolve any issues that may hinder study initiation or impact trial deliverables.

• Maintain accurate documentation to ensure preparedness for inspections.

• Assist sites during the activation phase until they reach “Green Light” status for site opening.

• Facilitate coordination with site staff to ensure all pre-study requirements, such as contracts, budgets, and essential documents, are fulfilled.

• Potentially support audit and inspection preparations to ensure compliance with regulatory and ethical standards.

⛳️ Requirements

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

• Must be based in Illinois, preferably near a major airport.

• Have 2-3 years of experience in monitoring clinical trials in the pharmaceutical industry.

• Minimum of 1-3 years' experience in monitoring clinical trials across various therapeutic areas.

• Knowledge across several therapeutic areas is required.

• Experience in study start-up as a CRA is essential.

• Analytical/risk-based monitoring experience is an asset.

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

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

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

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

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

• Comprehensive knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements.

• Applicants must be legally authorized to work in the United States and should 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.

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