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As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas.
Job Responsibility
Ensuring regulatory, ICH-GCP and protocol compliance
Verifying the process of obtaining informed consent
Assessing factors that might affect subject safety and clinical data integrity
Conducting monitoring activities using different methods (e.g., on site and remote)
Conducting source document review and verification
Managing reporting of protocol deviations
Applying query resolution techniques
Performing Investigational Product (IP) inventory, reconciliation and review
Verifying IP dispensation and administration
Managing reporting of identified issues
Documenting activities via follow-up letters, monitoring reports
Ensuring all activities are managed by appropriately delegated and trained site personnel
Entering data into tracking systems
Reviewing data entry timeliness
Reviewing site signature sheet and delegation of duties log
Conducting follow-up for escalated adverse event monitoring report queries
Checking site and external facilities, equipment, and supplies
Checking site specific logs
Collaborating with primary Site Manager
Preparing for and attending Investigator Meetings and sponsor meetings
Participating in global clinical monitoring and project staff meetings
Requirements
Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
Minimum of 5 years' experience in CRO or Pharma trials environments
Experience in oncology trials and RECIST criteria is essential
Fluency in English is required
Proficiency in local language is required
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