ICON plc · 14 hours ago
Clinical Research Associate (Start Up) - Oncology - Los Angeles, CA
Los Angeles, CA
Full-time
Hybrid
Entry, Mid Level
2+ years expICON Plc is a global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries. They are seeking a Clinical Research Associate with a focus on start-up activities in oncology to collaborate with teams in site selection and activation, ensuring compliance with regulatory standards.
Biotechnology
No H1B
Responsibilities
Works on multiple trials within the Cross Therapeutic areas - Start up focus
Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements
Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies
Build strong relationships with site personnel to facilitate a smooth onboarding process
Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs)
Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation
Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process
Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities
Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones
Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines
Proactively identify and address any issues that may delay study initiation or affect trial deliverables
Maintain precise documentation to ensure readiness for inspections
Support sites during the activation phase until they achieve “Green Light” status for site opening
Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met
Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards
Qualification
Required
Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
Must be located in the Los Angeles area; near a major airport
Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience specifically monitoring oncology clinical trials
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting)
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements
To qualify, 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
Preferred
Analytical/risk-based monitoring experience is an asset
Company
ICON plc
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Jack B. Yeager
CEO
John Barry
SVP and Chief Strategy Officer, SSD at ICON Global Strategic Solutions
Recent News
Business Post
2024-05-04
2024-05-03
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