Senior Cra I

il y a 6 jours

Paris, France Parexel Temps plein

Parexel are currently recruiting for a Senior Clinical Research Associate with oncology experience in France, to cover sites in and around Paris region.

In this role, the Senior Clinical Research Associate is responsible for field monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. This role may provide operational input to clinical study teams as directed.

**Some specifics about this advertised role**
- Act as liaison between the in-house team, vendors, and multiple clinical sites.
- Work collaboratively with investigative sites to develop strong, long-term, working relationships.
- Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
- Assist with start-up activities, including essential document review and collection as requested.
- Perform Site Initiation Visits.
- Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
- Perform Interim Monitoring Visits for assigned studies.

**Who are Parexel**

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

**What we are looking for in this role**

For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.

Here are a few requirements specific to this advertised role.
- BA/BS, or equivalent, or relevant experience and training with at least years of pharmaceutical/biotech experience. RN or health care professional preferred.
- Prior monitoring experience is required. Oncology/haematology clinical trial experience is essential.
- FDA/EMA inspection experience is preferred.
- Proficiency in CFR and GCP/ICH Guidelines is required. Experience working on global clinical trials is preferred.
- Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF).

**Not quite the role for you?**

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