Clinical Research Associate

  • Contract
  • Pharmaceutical

Are you a CRA with at least a few years’ experience and are you up to a new challenge? Or you are more experienced and ready to develop your career further? We can offer you a nice opportunity in the oncology department at a well-known pharmaceutical company. Experience in oncology is not a must. Interested? Apply today or contact us if you have questions!

Vacancy information

The Clinical Research Associate (CRA) has responsibility for the delivery of the studies at allocated investigator sites and is an active participant in the local study team(s). She/he works in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.

The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies.

Obtain and maintain essential documentation in compliance with ICH-GCP, the company’s Procedural Documents and local regulations both in the office and at site. Ensure expertise of the Trial Master File.

Actively participate in Local Study Team meetings.

Contribute to the selection of potential investigators, train, support and advise the investigators and site staff in study related matters.

Share information on patient recruitment and study site progress within local Study Team.

Utilize Risk Based Monitoring approach including remote monitoring.

Drive performance at the sites.  Proactively identify study-related issues and ensure query resolution.

Manage study supplies (ISF, CRF, etc.), drug supplies and drug accountability at study sites.

Perform source data verification and source data review per SDV plan.

Ensure accurate and timely reporting of Serious Adverse Events.

Prepare for activities associated with audits and regulatory inspections in liaison with LSTL.

Provide the required monitoring visit reports within required timelines (remote or on-site visits). 

Cooperate with Medical Science Liaisons in their support of the designated clinical studies.

Requirements information

qualification.

Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

Good knowledge of relevant local regulations with main focus on Belgium.

Good medical knowledge in relevant Therapeutic Areas is an asset: mainly oncology or cardiology / pulmonology.

Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Languages: first language Dutch or French, second language French or Dutch plus good knowledge of English for internal training and meetings sessions.

Residing in Belgium.

Sonia Vandekerkhove

Vacancy ID: 276

Senior Recruiter

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