Senior Clinical Research Associate Job at Parexel (Paris Region)

Job Description

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. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensuring regulatory, ICH-GCP and protocol compliance
Verifies the process of obtaining informed consent
Demonstrates diligence in protecting the confidentiality of each subject
Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods
Conducts source document review and verification
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
Manages reporting of identified issues and manages follow up to resolution
Documents activities via follow up letters, monitoring reports, communication logs
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, 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
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

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
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

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Senior Clinical Research Associate

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