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Job Details

CRA Belgium

Company: inVentiv Health Clinical
Location: Braine L'Alleud, Belgium
Reference: IH/6031
Closing Date: 17 Dec 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

A very nice sponsor-based CRA role.

Requirements:

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose:  shortening the distance from lab to life.  You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most.  In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

 

For our client, a global pharmaceutical organization we are currently looking for a Clinical Research Associate. In this role you will be working from the client’s office in Braine L’Alleud but you are allowed to work from home more often once you are fully trained.  

 

Your responsibilities will be as follows:

  • Expedites the pre-study and study initiation processes including the conduct of Pre-Study valuation and Site Initiation visits.
  • Conducts Site Initiation visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
  • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators.
  • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations. This includes, but is not limited to: - Manages multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
  • Ensures quality of data submitted from study sites and assures timely submission of data.
  • Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH and/or FDA GCP Guidelines.
  • Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives.
  • Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
  • Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
  • Appropriately escalates serious or outstanding issues to line manager and project team members.
  • Facilitates the Regulatory Compliance audit process, as needed.
  • Provides monitoring assistance to site monitor colleagues, as requested, in addition to serving as a mentor to other colleagues as assigned.
  • Proactively communicates and escalates with all internal and external stakeholders any issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
  • Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist), peers, and office-based personnel.
  • Uses multiple technologies to foster, maintain, and enhance open communication

 

 

The ideal candidate has:

  • Minimum of BA/BS, or equivalent, from an accredited institution                                                                                                                                                                                                                                                                                                                                                                  
  • Minimum 2-3 years as site monitor/CRA clinical research experience
  • Fluent in English, French and Dutch language (written and oral)
  • Able to be flexible
  • Able to manage site relationships
  • Critical thinking
  • Basic GCP/FDA/HA knowledge
  • Competence in computer based tools / systems
  • Able to work in team environment / matrix
  • Able to work in multiple parallel projects

 

Additional skills:

  • Exhibits a high level of flexibility and sets an example for the department when facing changes such as program priorities, protocol modifications, enrollment challenges, etc.
  • Employs good fiscal management to conserve the costs of departmental operation and controls travel expenses.
  • Previous large pharmaceutical experience preferred.
  • Demonstrated success in working independently
  • Strong communication and leadership skills
  • Ability to work independently

 

How to apply?

Are you ready to work alongside the brightest minds at INC Research/inVentiv Health? In this role you’ll be fully employed by INC Research/inVentiv Health and will enjoy our very competitive primary and secondary benefits. Please contact Eveline Wigtman or Irene Houtsma via beneluxjobs@inventivhealth.com  with reference to job number 6031.

 

Apply for this job: CRA Belgium

Contact Information:

Address:  France
41 rue des trois Fontanot
92 000 Nanterre

France
Reasons to work for inVentiv Health Clinical
Website:  Visit Our Web Site

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