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