Clinical Research Associate

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Ver: 115

Día de actualización: 26-11-2025

Ubicación: Antwerp City Antwerp

Categoría: R & D IT - Software

Industria: Staffing Recruiting

Posición: Entry level

Tipo de empleo: Contract

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Contenido de trabajo

As aClinical Research Associate (CRA) you are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trial according to the study protocol, ICH-GCP, applicable regulations, guidelines and sponsor requirements.Some Of What You Will Do
  • Identify investigator sites and participate in the feasibility process for new studies
  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCP
  • Perform visits remotely according to foreseen applicable procedures and timeframes
  • Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission
  • Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets
  • Check the correct submission and completion of informed consent forms
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
  • Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures
  • Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
Requirements
  • Enthusiastic, knowledgeable and proactive
  • University degree in a scientific/life science field
  • At least 2 years of experience in managing and conducting clinical trials
  • In depth knowledge of ICH GCP principles
  • Able to carry out independently all the activities related to the monitoring of clinical trials
  • Good knowledge of Office Suite (Word, Excel, PowerPoint)
  • Organizational and problem-solving skills
  • Excellent written and verbal communication skills including good command of English language
  • No restrictions to travel onsite
Who We AreOPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.Please read the information notice on the processing of personal data in the candidates information section of our company website.
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Plazo: 10-01-2026

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