Clinical Research Associate I/II (CRA I/II) - Clinical Operations - Paris, France

Manages Others
Yes
Experience Required
Yes
Degree Required
Yes
Employment Type
Employee
Work Schedule
Full-Time
Travel
Some Travel

Job Description
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career?
Job Requirements
We are currently recruiting for a Clinical Research Associate I/II to our Clinical Operations department. We are looking for candidates willing to be office-based in Paris during the probation period/ then there will be a possibility of home-office!

Role description:

• Ensure the study staff have received the proper materials and instructions to safely enter patients into the study

• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

• Monitor data for missing or implausible data

• Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner

• Prepare accurate and timely trip reports

• Manage small projects under direction of a Project Manager/Director as assigned

• Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned

• Review progress of projects and initiate appropriate actions to achieve target objectives

• Organize and make presentations at Investigator Meetings

• Participate in the development of protocols and Case Report Forms as assigned

• Participate in writing clinical trial reports as assigned

• Interact with internal work groups to evaluate needs, resources and timelines

• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned • Undertake feasibility work when requested

• Conduct, report and follow-up on Quality Control Visits (CQC) when requested

• Recruitment of potential investigators, preparation of EC submissions, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

• Negotiate study budgets with potential investigators and assist the Covance / Sponsor - legal department with statements of agreements as assigned

• Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

• Assist with training, mentoring and development of new employees, e.g. co-monitoring

• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

Requirements:

• 2-3 years of Clinical Monitoring experience including oncology experience

• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries

• Thorough understanding of the drug development process

• Fluent in local office language and in English, both written and verbal


Keywords: CRA II, Clinical Research, CRA, Clinical Research Associate, GCP, Monitor, Monitoring, Senior, CRA I, CRA II, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Field Based, office-based, CRO, Pharmaceutical, Paris, France
Employer Contact Information
Covance
Aleksandra Lawaty-Cichy


Poland

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