Clinical Research Associate II (CRA Level II) - France

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Ivry-sur-Seine, Île-de-France - France
Senior Specialist / Project Manager
Pharmaceutical Research Industry
 
Job Description - Clinical Research Associate II (CRA Level II) - France (163374)

Job Description 

Clinical Research Associate II (CRA Level II) - France - 163374

Description

 

Sr CRA or CRA II - France (office or home based)

PPD is currently looking for experienced CRAs to join our clinical monitoring team in France as CRA II or Sr CRA depending on experience.  These positions are permanent and can be either office based in Paris or home based.

PPD is a leading global contract research organization with more than 21,000 staff globally.  At PPD we are passionate, professional and driven by our purpose - to improve health.

PPD’s Clinical Monitoring Team is made up of monitors with institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

As a CRA, you will ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to help our clients deliver life-changing therapies to patients.

Responsibilities:

  • Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification).
  • Assess investigational product through physical inventory and records review
  • Documents observations in reports and letters in a timely manner using approved business writing standards
  • Escalates observed deficiencies and issues to clinical management expeditiously, present potential solutions and follow all issues through to resolution
  • Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner
  • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted
  • Performs trial close out and retrieval of trial materials.
  • Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
  • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
  • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.

Grow within the CRA career path to Sr CRA II or PCRA or develop into a line manager role.  CRAs often transition to our client dedicated teams and to becoming CTMs working alongside our Project Management team responsible for clinical deliverables on our studies.

Qualifications

 Qualifications
 
Education and Experience:
  • Bachelor's degree in a life sciences related field
  • Minimum 1 year+ as a CRA at a CRO or pharma company
  • Previous TA experience in Oncology, Haematology or Intensive/Critical Care is beneficial
  • Valid driver's license where applicable.

Knowledge, Skills and Abilities: 

  • Proven clinical monitoring skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
  • Effective interpersonal skills
  • Ability to remain flexible and adaptable in a wide range of scenarios
  • Ability to work in a team or independently as required
  • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
  • Fluent French and English language and grammar skills

Please apply now or contact Adam Davis, Senior Recruiter, on adam.davis@ppdi.com for more information.

Organization

 - Clinical Research Associates

Primary Location

 - FR-FR-Ivry-sur-Seine Ced-Ivry-sur-Seine Cedex FR PVC