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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
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
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
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
Conducts follow up for escalated adverse event monitoring (AEM) report queries
Checks the site and external facilities, equipment, and supplies continue to be adequate to conduct the trial
Checks site specific logs are complete and up to date
Collaborates with primary Site Manager
Prepares for and attends Investigator Meetings and sponsor face to face meetings
Participates 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
Recent oncology experience will be essential
Proficiency in local language is required
Advanced level or fluency in English 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