Clinical Research Associate

hace 4 semanas

Madrid, Madrid, España Tfs Healthscience A tiempo completo

Clinical research is a rapidly evolving field, and we're looking for an experienced professional to join our team as a Clinical Research Associate in onco-hematology trials. As part of our SRS/FSP team, you'll work closely with a global biotech company that's a leader in this therapeutic area.

Responsibilities

As a Clinical Research Associate, your key responsibilities will include:

  • Monitoring clinical trials on-site and remotely to ensure compliance with TFS and/or client company SOPs, FDA regulations, and GCP and ICH guidelines.
  • Reviewing CRFs and subject source documentation for validity and accuracy, generating queries to investigational sites or clients to resolve any discrepancies.
  • Identifying site problems or deficiencies and reporting them to management through trip reports, memos, and verbal communication with the project manager or lead CRA.
  • Initiating corrective action to resolve issues as directed by your supervisor.
  • Contributing to the completion of ethics committee/IRB applications, preparing necessary documentation, and coordinating with the CTA and lead CRA/project manager.
  • Participating in contract handling and negotiation, as directed by the lead CRA/project manager.
  • Setting up ISF and SMF (or cooperating with the CTA) and distributing them to investigational sites.
  • Maintaining SMF, ordering, shipping, and reconciling clinical investigative supplies for study sites, if applicable.
  • Preparing and submitting status reports as directed by the lead CRA/project manager.
  • Reviewing and supporting site staff to maintain SMF.
  • Reviewing informed consent documents for essential elements and protocol specifics.
  • Updating the CTMS system with site and study information.

The ideal candidate will have a bachelor's degree in a life science or nursing discipline, with a minimum 1-2 years of relevant clinical experience. They should be able to work in a fast-paced environment with changing priorities, understand basic medical terminology and science associated with assigned drugs and therapeutic areas, possess knowledge of Good Clinical Practice regulations and ICH guidelines, and demonstrate excellent written and verbal communication skills.

About Us

Tfs Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and functional service (FSP) solutions. We value collaboration, innovation, and making a difference in the lives of patients.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. You'll be joining a team that values trust, quality, passion, flexibility, and sustainability, guiding our decision-making at all levels of the organization.

Compensation Package

We offer a salary range of $80,000-$110,000 per annum, depending on your level of experience and qualifications. Additionally, you'll receive comprehensive benefits, including health insurance, a lunch allowance, flexible remuneration, overtime compensation, summer working hours, and flexibility.

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