Senior Clinical Research Associate

• Responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level
• Monitoring will be conducted in line with the Study Monitoring Plan (SMP)
• Collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready
• Coordinate with institutions and investigators at the local level
• Oversight of Monitoring Responsibilities and Study Conduct
• Ensuring regulatory, ICH-GCP and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject
• Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity
• Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations
• Conducts source document review and verification of appropriate site source documents and medical records
• Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
• Manages reporting of protocol deviations and appropriate follow up
• Applies query resolution techniques remotely and on site
• May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security
• Verifies the IP has been dispensed and administered to subjects according to the protocol
• Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned
• Manages reporting of identified issues and manages follow up to resolution
• Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents
• Ensures all activities are managed by site personnel who are appropriately delegated and trained
• Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• For assigned activities, understands project scope, budgets, and timelines
• Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks
• Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately
• Conducts follow up for escalated adverse event monitoring (AEM) report queries
• Checks the site and external facilities, equipment, and supplies (clinical and non-clinical) continue to be adequate to conduct the trial
• Checks site specific logs are complete and up to date
• Collaboration
• Collaborates with primary Site Manager who will act as the primary liaison with site personnel
• Prepares for and attends Investigator Meetings and sponsor face to face meetings
• Participates in global clinical monitoring and project staff meetings and attends clinic

• Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
• Networking and relationship building skills
• Ability to communicate effectively and appropriately with internal and external stakeholders
• Ability to adapt to changing technologies and processes
• Excellent communication (verbal and written), presentation, and interpersonal skills
• Identifies and builds effective relationships with investigator site staff and other stakeholders
• Proficiency in local language is required
• Advanced level or fluency in English is required

Oncology Experience

• Patient-focused in everything we do
• Supportive and inclusive environment
• Career growth and development
• Flexible work arrangements
• Diverse therapeutic areas and project exposure
• Advanced Technology