Senior Clinical Research Associate - Oncology

About This Role

Monitor investigator sites using a risk-based approach, ensuring data accuracy and compliance with protocols and regulatory obligations. Document observations, escalate issues to management, and contribute to the overall project team's success in clinical trial execution.

Responsibilities

• Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking and problem-solving skills.
• Ensure data accuracy through SDR, SDV and CRF review via on-site and remote monitoring.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters in a timely manner.
• Escalate observed deficiencies and issues to clinical management and follow through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence and issue resolution.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• Ensure study systems are updated per agreed study conventions (e.g., CTMS).
• Participate in investigator meetings and identify potential investigators in collaboration with the client company.
• Conduct on-site file reviews as per project specifications.

Requirements

• Bachelor's degree in a life science related field or Registered Nursing certification
• 2+ years of experience as a traveling clinical research associate
• Effective clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Effective oral and written communication skills
• Good computer skills: proficient knowledge of Microsoft Office

Qualifications

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• 2+ years as traveling clinical research associate or equivalent experience.

Skills

* Required skills

Benefits