Senior Clinical Research Associate – Oncology Experience Required

• Ensure regulatory, ICH-GCP, protocol, and local-requirement compliance at investigator sites
• Evaluate site and site-staff performance, communicate significant issues, and develop action plans
• Verify informed-consent processes, subject confidentiality, safety factors, protocol deviations, and pharmacovigilance issues
• Conduct on-site and remote monitoring activities according to the Monitoring Plan
• Perform source document review and verify clinical data in Case Report Forms
• Manage protocol deviations, data queries, adverse-event monitoring queries, and follow-up to resolution
• Review investigational-product inventory, storage, dispensing, administration, labeling, import, release, and return
• Document monitoring activities in reports, follow-up letters, communication logs, and project documents
• Track observations, action items, data-entry timeliness, missing pages, queries, database-lock timelines, delegation logs, and training compliance
• Check site facilities, equipment, supplies, and study logs
• Collaborate with the Site Manager, site personnel, investigators, institutions, sponsor representatives, and global project teams
• Prepare for and attend Investigator Meetings, sponsor meetings, clinical monitoring meetings, and clinic visits

Requirements

• Experience in oncology trials and RECIST criteria is essential
• Bachelor’s degree or Registered Nurse (RN) in a related field, or equivalent combination of education, training, and experience
• Proficiency in the local language is required
• Advanced level or fluency in English is required
• Knowledge of ICH/GCP Guidelines, applicable guidance, relevant regulations, and company SOPs/processes
• Ability to conduct on-site and remote monitoring where permitted by country regulations
• Networking and relationship-building skills
• Effective communication with internal and external stakeholders
• Ability to adapt to changing technologies and processes
• Ability to overcome barriers during implementation of new processes and systems
• Excellent verbal and written communication, presentation, and interpersonal skills
• Ability to identify and build relationships with investigator site staff and stakeholders
• Ability to manage site-level activities, communications, project objectives, deliverables, budgets, and timelines
• Must be able to adapt quickly to changing priorities

Core Competencies

Demonstrates expertise in regulatory compliance, particularly ICH-GCP and protocol adherence, while effectively managing oncology trial activities and stakeholder communications. Proficient in monitoring processes, data verification, and relationship-building within clinical research environments.

Highest-signal resume keywords

• Oncology Trials Experience
• ICH/GCP Guidelines Knowledge
• Informed Consent Verification
• Effective Communication Skills
• Site Management

ATS Optimization Keywords

Hard Skills

• Regulatory Compliance
• Clinical Data Verification
• Source Document Review
• Adverse Event Monitoring
• Protocol Deviation Management
• Data Query Resolution
• Monitoring Plan Execution
• Case Report Form Review
• Pharmacovigilance
• RECIST Criteria Knowledge

Soft Skills

• Networking Skills
• Relationship-Building
• Adaptability
• Interpersonal Skills
• Presentation Skills

Certifications & Qualifications

• Bachelor’s Degree
• Registered Nurse (RN)

Industry Keywords

• Clinical Trials
• Investigator Meetings
• Site Staff Performance Evaluation
• Clinical Monitoring
• Study Logs
• Project Objectives Management
• Timelines Management
• Local Language Proficiency
• English Fluency
• SOPs/Processes Knowledge