Senior Clinical Research Associate I (Oncology experience required) - France, Paris region - FSP

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

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 inhouse team vendors and multiple clinical sites.

• Work collaboratively with investigative sites to develop strong longterm working relationships.

• Apply SOPs Clinical Monitoring Plan (CMP) study manuals and other materials and guidelines as applicable.

• Help identify and qualify potential investigators. Perform PreStudy Site Visits.

• Assist with startup 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 todays top 50 bestselling drugs but equally we enable more niche drug developments that are critical to the wellbeing of many patients.

Youll 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 wellbeing 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).

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