CRA II/Senior CRA - France
An international contract research organisation is advertising a vacancy for a Clinical Research Associate II. The company, which provides drug discovery, lifecycle management, and laboratory services, is seeking for a driven and talented individual to join their company in their office in Paris. This is an exciting opportunity to work with a company that provides innovative ideas behind multiple pharmaceutical sectors.
- Monitoring investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification).
- Assessing investigational product through physical inventory and records review.
- Documenting observations in reports and letters in a timely manner, using approved business writing standards.
- Escalating observed deficiencies and issues to clinical management expeditiously, presenting potential solutions, and following all issues through to resolution.
- Maintaining 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.
- Initiating clinical trial sites according to the relevant procedures to ensure compliance with the protocol, regulatory, and ICH GCP obligations, making recommendations where warranted.
- Performing trial close out and retrieval of trial materials.
- Managing the essential documents, as required by local regulations and ICH GCP, before, during, and after a clinical trial.
- Providing trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
- Facilitating effective communication between investigative sites, the client company, and the company's project team through written, oral, and/or electronic contacts.
- Contributing to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions with team members.
Skills and Requirements:
- 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.
- Proven clinical monitoring skills.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Fluent French and English language and grammar skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Valeria Cardo at +44 203 854 0674 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.