Clinical Research Associate
hace 1 día
Clinical Trial Coordinator Role in Madrid for Global Biotech Company
About Our Client: TFS HealthScience is a leading Contract Research Organization (CRO) that partners with pharmaceutical and biotechnology companies worldwide.
Job Summary: As a Clinical Research Associate, you will be dedicated to one sponsor, a global biotech company leader in onco-hematology. Your primary responsibilities will include monitoring clinical trials, reviewing Case Report Forms (CRFs), identifying site problems, and contributing to Ethics Committee applications.
Key Responsibilities:
- Conduct site visits and remotely monitor clinical trials according to GCP and ICH guidelines, as well as FDA regulations.
- Review CRFs for accuracy, generate queries, and resolve data discrepancies.
- Identify site issues and report them to management through trip reports, memos, and verbal communication.
- Initiate corrective actions to resolve issues directed by your supervisor.
- Participate in contract handling and negotiation, set up ISF and SMF, and distribute them to investigational sites.
- Maintain SMF, order clinical investigative supplies, and review Informed Consent documents.
Qualifications: To succeed in this role, you should possess a Bachelor's Degree in life sciences or nursing, have minimum 1-2 years of relevant experience, and understand Good Clinical Practice regulations, ICH guidelines, and basic medical terminology.
Benefits: We offer a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment.
Estimated Salary: €55,000 - €65,000 per annum, depending on location and experience. You will work in a fast-paced environment with changing priorities, collaborating with a team matrix organization.
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