Clinical Research Associate (Start Up) - Oncology

About This Role

This role manages multiple clinical trials in Oncology, focusing on site activation and ensuring compliance with regulatory standards. It involves collaborating with country operations teams, performing site qualification visits, and acting as the main contact for stakeholders throughout the start-up process.

Responsibilities

• Work on multiple clinical trials within the Oncology Therapeutic area with a start-up focus
• Collaborate with country operations teams to identify, select, and activate clinical trial sites
• Perform Site Qualification Visits (SQVs) to assess site eligibility
• Build strong relationships with site personnel for smooth onboarding
• Ensure all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal SOPs
• Coordinate with country operations to collect essential documents for timely site activation
• Act as the main point of contact for sites, study teams, and external stakeholders
• Manage investigator contracts, regulatory documents, and site-specific start-up activities
• Provide regular status updates to internal and external stakeholders
• Monitor, report on, and analyze Key Performance Indicators (KPIs) related to site selection and start-up timelines
• Proactively identify and address 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 'Green Light' status is achieved
• Facilitate coordination with site staff to meet all pre-study requirements
• Possibly assist in audit and inspection preparations to guarantee compliance

Requirements

• Minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
• Located in Pennsylvania, near a major airport
• 2-3 years’ experience in monitoring pharmaceutical industry clinical trials
• 1-3 years' experience monitoring oncology clinical trials
• Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, IWRS)
• Strong communication and influencing skills
• In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements
• Legally authorized to work in the United States without sponsorship

Qualifications

• B.S., R.N., or equivalent degree, preferably in Biological Sciences
• 2-3 years’ experience in monitoring pharmaceutical industry clinical trials and 1-3 years' experience monitoring oncology clinical trials

Nice to Have

• Analytical/risk-based monitoring experience
• Ability to actively drive patient recruitment strategies
• Ability to partner with investigator and site staff

Skills

* Required skills

Benefits