Clinical Research Associate Ii, France

**Clinical Research Associate II / CRA II**

Location: Paris home office, France

A formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas - improving health and lives every day.

**What you can expect from us**:

- flexible working hours, capped overtime and compensatory time off in lieu
- travel time = work time
- highly competitive compensation packages
- subsidized meals and transportation allowances
- bonus schemes / profit sharing
- regular, merit-based salary adjustments
- significant employer contribution to an attractive pension scheme
- extensive insurance coverage, including medical, life, short as well as permanent disability and accidents
- excellent training and career development opportunities as well as support with furthering your education
- strong support from Line Management and more than 20'000 colleagues worldwide
- the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years

**Your responsibilities**:

- Own all aspects of site management as described in the project plans.
- Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study.
- Protect 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 diligently reviewing source documents. Monitor data for missing or implausible entries.
- Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; submit accurate and timely trip reports.
- Review progress of projects and initiate appropriate actions to achieve target objectives.
- Act as a primary contact for clinical trial suppliers and other vendors.
- Own the entire process of Serious Adverse Event (SAE) reporting
- Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems

**Education**:

- Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, etc.
- In lieu of the above, a valid certification in health / life sciences by an accredited institute

**Experience**:

- Solid independent monitoring experience in France as CRA, with a focus on complex clinical trials (phases II and III)
- Proven experience in a variety of therapeutic areas, preferably including oncology
- Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the French regulatory authorities landscape
- IT-literate, including Microsoft Word, Excel, PowerPoint, and preferably eTMF solutions such as Veeva Vault
- Effective time management and organizational skills and a keen attention to detail
- Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
- ** Excellent communication skills in both French and English - spoken and written - are a must**

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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