Clinical Research Associate II

Hobson Prior are looking for a Clinical Research Associate II to join a world-wide biopharmaceutical organisation who specialize in oncology product development and pioneering medicines that are used all over the world. This is a permanent position located in Paris.

Job Responsibilities:

• Accountable for evaluation, initiation, monitoring, close-out and other tasks associated with the management of clinical sites.
• Act as the primary contact for Clinical Research Organizations/ vendors, Investigators and study coordinators for study related questions.
• To ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures.
• In conjunction with study team support feasibility and site selection process for clinical studies.
• Supports country submissions and country requests as needed.
• Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.).
• Manage patient recruitment strategies to increase patient randomization into the trial (eg investigator and research nurse meetings, update newsletters, advertising, targeted letters…).
• Review all Adverse Events/Serious Adverse Events and ensure appropriate documentation is in place and any other safety issues are addressed and communicated.
• Assist and support data validation and data cleaning procedures to ensure timelines are met.
• Order and coordinate study supplies for clinical studies.
• Develop and maintain tracking tools to support management of clinical studies.
• Plan and participate in Investigator meetings and Clinical Research Associate trainings.

Key Skills:

• Capability to handle and prioritize multiple studies and projects.
• Capability to work effectively in a team/matrix environment.
• Ability to understand technical, scientific and medical information.
• Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills.

Requirements:

• Bachelor or nurse degree, preferably in the Life Sciences is required.
• Minimum of 2+ years of experience in the pharmaceutical / biotechnology industry or CRO as a Clinical Research Associate from study start-up to database lock.
• Strong Oncology monitoring experience in phases 1-3 pharmaceutical/ biotechnology clinical trials.
• Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, patient privacy laws, and other relevant, and country regulatory requirements.
• Good knowledge of concepts of clinical research and drug development.
• Strong working knowledge of Electronic Data Capture, Interactive Voice/Web Response System and Clinical Trial Management System.
• Fluent in French and English, oral and written.
• Ability to travel 80% of working time or more.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.