Clinical Research Associate

Benefits

Qualifications

• •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
• •Analytical/risk-based monitoring experience is an asset
• •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
• •9 more items(s)

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
• •12 more items(s)