Senior Clinical Research Associate

• Manage 2–3 clinical trials and site management activities
• Conduct study start-up, site selection, site evaluation, initiation, monitoring and closeout activities
• Keep current with scientific, regulatory and operational aspects relevant to assigned clinical projects
• Train site staff in study procedures
• Conduct periodic on-site and remote monitoring visits and complete monitoring visit reports
• Review Case Report Forms for accuracy, legibility, completeness and quality
• Perform source data verification and in-house clinical data review
• Resolve data queries in a timely manner
• Manage investigational products and trial materials, including storage, inventory, dispensing records, packaging, labelling and study files
• Coordinate safety issue reporting and follow-up for AEs, SAEs and SUSARs
• Conduct and report study termination and archiving activities
• Serve as the main contact for investigative sites
• Support the Clinical Research Division with clinical data quality control
• Escalate issues that may jeopardize assigned clinical projects
• Report study activities and submit relevant documents to the Head of Department
• Develop training materials and deliver training with the Training & Qualification Management Unit
• Assist with site study budget contract negotiation after appropriate training
• Assist with CRF design/development, CRF instructions and study file organization
• Support project submissions, submission requirements, timelines and informed consent development
• Guide and supervise CRA I staff

• University Degree in scientific, medical or paramedical disciplines
• Previous experience working for a CRO is required
• At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate performing on-site monitoring activities
• Experience monitoring oncology, respiratory and complex clinical trials is required
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines and applicable regulatory requirements
• Fluent in English and local language(s)
• Proficiency in Microsoft Office, including Word, Excel and Outlook
• Willingness to travel to investigative sites as needed

Demonstrates extensive experience in managing clinical trials, including site management, monitoring, and compliance with GCP/ICH Guidelines. Proficient in training site staff and ensuring data quality control while effectively communicating with investigative sites.

• Clinical Trial Management
• On-Site Monitoring Activities
• GCP/ICH Guidelines Knowledge
• Clinical Research Experience
• Microsoft Office Proficiency

• Clinical Trial Operations
• Data Verification
• Source Data Review
• Case Report Form Review
• Safety Issue Reporting
• Study Budget Negotiation
• CRF Design/Development
• Training Material Development
• Monitoring Visit Reporting
• Investigational Product Management

• Communication
• Training
• Problem-Solving
• Team Leadership

• Clinical Research Organization
• Oncology Trials
• Respiratory Trials
• Complex Clinical Trials
• Regulatory Requirements
• Study Start-Up
• Site Selection
• Site Evaluation
• Adverse Event Reporting
• Informed Consent Development