SCRA

A leading pharmaceutical company is seeking to recruit a Senior CRA to their office in Madrid on a home-based capacity. The organisation provides expertise in Clinical Trials, Regulatory Affairs, and Pharmacovigilance. This position is an exciting opportunity to join a professional and innovative organisation and have an impact on the clinical field.

Job Responsibilities:

• Performing country feasibilities, recruiting potential investigators, preparing EC submissions, translating study-related documentation, and organizing of meetings and other tasks as instructed by supervisor.
• Negotiating study budgets with potential investigators/sites and assisting in agreements negotiation.
• Performing regulatory document review/local adaptation and submission to regulatory Authorities.
• Conducting pre-study, initiation, monitoring, and closeout visits for research sites.
• Performing source document verification and case report form review.
• Checking drug storage conditions and accountability through clinical trial.
• Performing adverse event and serious adverse event reporting and follow-up.
• Assessing patient recruitment and retention.
• Site administrating and site monitoring responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines, and GCP.
• Completing Serious Adverse Event (SAE) reporting, processing production of reports.
• Managing investigator/site payments.
• Manage and oversight Local Regulatory Officers and Regulatory Affairs Specialist to ensure appropriate communication channels are maintained and reporting schedules adhered to.

Skills and Requirements:

• Education in Science in health-related field.
• At least 3 years CRA experience.
• Experience in RA submissions preparation.
• Excellent knowledge of English language, both oral and written.
• Thorough knowledge of ICH Guidelines and GCP.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Andrea Rotmistrovsky at +44 203 854 0675 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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