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Herakles Pharma

Clinical Research Associate (homebased / officebased)

Functiegroep: Clinical Operations
Procedure: W&S
Vacature ID:#650

Clinical Research Associate (homebased / officebased)

De organisatie

Our client is actively recruiting for a Clinical Research Associate to join their expanding global company in the Belgium, home of office based opportunity. You can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Our client is a dynamic and privately owned company with a presence in over 50 countries worldwide. They have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. They have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

De functie

The Clinical Research Associate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Responsibilities of the Clinical Research Associate:

  • Monitor clinical trials to ensure adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures;
  • Manage study sites to ensure proper adherence to protocol, informed consent procedures, source data verification, compliance to safety reporting procedures and assess CRF entries;
  • Perform pre-study initiation, interim monitoring and close out visits as required;
  • Report promptly and in accordance with sponsor SOPs and ICH-GCP and local regulatory;
  • Requirements any Serious Adverse Events reported by sites to relevant sponsor contact and /or Regulatory Authority contact as appropriate;
  • Distribute SUSARs (Suspected unexpected serious adverse reaction) in accordance with IEC & local regulatory requirements;
  • Ensure adequacy of drug shipment and drug accountability (and storage times and conditions are acceptable or and compliance with GMP);
  • Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required;
  • Organise / attend investigator meetings as required;
  • Attend and contribute to Client meetings as and when requested and follow up on assigned actions to completion;
  • Raise awareness via his/her manager of potential issues;
  • Provide support to the Project Manager / Country Manager with ad-hoc tasks as required;
  • Perform feasibility assessments & site evaluations as required.

Het profiel

Essential requirements for the function as a Clinical Research Associate:

  • Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline;
  • Clear understanding of the drug development process;
  • Significant experience in performing a Clinical Research Associate role;
  • Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company;
  • Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials;
  • Ability to contribute to the development of clinical trial related documents and materials;
  • Ability to independently perform pre-study initiation, interim monitoring and close out visits as required;
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines;
  • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail;
  • Fluency in English and (both written and spoken);
  • Willingness and ability to travel;
  • Willingness and ability to be home based in Belgium.

Desirable requirements for the function as a Clinical Research Associate:

  • Experience across a wide range of clinical indications / therapeutic areas;
  • Ability and experience to work with an electronic case report form (eCRF);
  • Membership of local professional bodies or international clinical groups;
  • Ability to mentor, train, supervise and inspire confidence in newcomers to the industry.

Inlichtingen bij

Interested in this opportunity as a Clinical Research Associate? Please respond via this page. For questions please contact Albert Hollemans via / 06-22639519


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