Overview
As a CRA, you will join the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence.
Responsibilities
What will you be doing?
- Manage multiple trials within various therapeutic areas, focusing on start-up activities.
- Collaborate with country operations teams to identify, select, and activate clinical trial sites according to project timelines and requirements.
- Perform Site Qualification Visits (SQVs) to assess site eligibility for specific clinical studies.
- Build strong relationships with site personnel to facilitate smooth onboarding.
- Ensure activities adhere to ICH-GCP guidelines, local regulations, and SOPs.
- Coordinate with the team to collect essential documents for site activation.
- Act as the main contact point for sites, study teams, and external stakeholders during start-up.
- Manage investigator contracts, regulatory documents, and site start-up activities.
- Provide regular updates to stakeholders on project milestones and KPIs.
- Identify and resolve issues that may delay study initiation or impact trial deliverables.
- Maintain detailed documentation for inspections.
- Support sites during activation until they achieve “Green Light” status.
- Coordinate pre-study requirements like contracts, budgets, and documentation.
- Assist in audit and inspection preparations to ensure compliance.
Qualifications
What do you need to have?
- B.S., R.N., or equivalent degree, preferably in Biological Sciences.
- Located in the Los Angeles area, near a major airport.
- 2-3 years’ experience in monitoring pharmaceutical industry clinical trials.
- 1-3 years' experience monitoring cross-therapeutic area trials.
- Knowledge of multiple therapeutic areas.
- Experience with analytical/risk-based monitoring is a plus.
- Ability to drive patient recruitment strategies.
- Strong partnership skills with investigators and site staff to meet timelines.
- Proficiency with systems like CTMS, EDC, eTMF, IWRS, and safety reporting.
- Excellent communication and influencing skills, capable of working remotely and face-to-face.
- Deep understanding of GCP, ICH guidelines, and local regulations.
- Legally authorized to work in the U.S. without future sponsorship needs.
What ICON can offer you:
Our success depends on our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. Benefits include:
- Various leave entitlements
- Health insurance options
- Retirement plans
- Global Employee Assistance Programme
- Life assurance
- Other country-specific benefits like childcare vouchers, gym discounts, and more.
Learn more at: https://careers.iconplc.com/benefits
ICON values inclusion and diversity. We are committed to providing an accessible environment and equal employment opportunities. If you need accommodations during the application process, please let us know.
Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we’re looking for!