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Clinical Site Coordinator (H/F/X)

January 29th 2024

iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UClouvain) in 2011.

Mission Description

The Clinical Site Coordinator is a permanent member of the Study Team and will be accountable for overseeing all the monitoring and site management activities. The CSC maintains a constant line of communication with the Clinical Trial Manager (or appropriate designee) from the relevant CRO, the Clinical Study Team, and other cross functional lines ensuring effective and efficient delivery of Site Activation, by overseeing start-up activities, through to Site Closure, and to ensure site activities are compliant with ICH-GCP and relevant protocol.

MAIN RESPONSIBILITIES:

SITE MANAGEMENT

  • Responsible for follow-up and tracking of site identification and selection progress.
  • Work with Clinical Study Team, CRO and STL to oversee site selection and feasibility which includes tracking CDAs and contributing to and reviewing feasibility questionnaires, reviewing feasibility documentation, and work with potential sites to prepare for the site qualification visits (SQV).
  • Oversee site start up and site management activities by CRO.
  • Work with STL regarding site recruitment and retention activity and report trends or issues to study team in effective, timely manner.
  • Prepare site status updates at each Study Team meeting.
  • Prioritize and resolve time management obstacles for site related issues.

MONITORING OVERSIGHT

  • Responsible for monitoring oversight by developing and implementing a robust monitoring oversight plan.
  • Follow-up and track monitoring performance by using metrics, provide status update to the study team.
  • Perform accompanied field visits, report findings and follow-up actions to resolution.
  • Review Monitoring visit Reports, identify risks/issues and follow-up actions or CAPAs if needed.
  • Perform site level TMF QC on site related documents.
  • Provide operational support to the Study Team in the management of clinical trials.
  • Propose new processes, ideas, and enhancements to improve efficiency and accuracy of work.

Candidate profile

  • BS/BSc/MS/MSc in scientific or biomedical fields or equivalent by experience
  • 3-5 years of clinical research experience with an emphasis on clinical trials, site management and CRO management.
  • 3+ years of experience as CRA. Being part of a start-up Team and/or having worked as Clinical Site Coordinator is an advantage.
  • Ability to project management multiple studies and ad hoc requests; experience preferred in the clinical development area.
  • Ability to lead, troubleshoot and influence for delivery.
  • Ability to collaborate in fast paced team environment and function Independently.
  • Good organization, planning, teamwork and communication skills.
  • Study start-up and critical path activities leading to site activation and monitoring.
  • Robust knowledge of core competencies associated with monitoring.
  • GCP knowledge.

Offer

  • A stimulating position within a high-potential innovative biotech company.
  • The opportunity to work in a science-driven, dynamic, respectful, and professional environment.
  • A challenging scientific and business growth in which you get to bring your knowledge and skills.
  • An employment agreement contract with an attractive salary package in line with the position responsibilities and your experience.

Contact Details

Please send your CV together with an adapted cover letter to the following address: jobs@iteostherapeutics.com. Please, mention the reference CSC in the mail object. Your application and related information will remain strictly confidential.

For this open position in Belgium, we closely collaborate with PaHRtners (Recruitment & Selection company). Your application will be automatically forwarded to them. We, together with PaHRtners, will keep all your data confidential (GDPR compliant approach).