KNOWLEGMENT:

• Computer proficiency in Microsoft Office and other computer tools
• Good knowledge of English language, good written and verbal skills (in English and country working language).
• Knowledge of medical terminology preferred, but not mandatory.

PURPOSE

• Give support to required study activities, mainly focused on the study documentation and archiving activities.
• Assure adherence to ICH-GCP guidelines, client/LR´SOPs and local regulatory requirements, compliance with the protocol.
• Give support to operations department of the Company.
• Demonstrate capacity and commitment with León Research values and philosophy.

ROLES

• Work under the rules of Good Clinical Practice and the Harmonization Guidelines (GCP-ICH Guidelines) to ensure the quality of the study data and documentation.
• Assure adherence to ICH-GCP guidelines, client/LR SOP´s and local regulatory requirements, and compliance with protocols.
• Communicate with sponsors, sites, and colleagues to ensure effective project development under the supervision of a Senior partner or line manager.
• Offer assistance to other León Research CRAs and to the sites.
• Give support with processes of submission, monitoring projects and documentation tasks.

RESPONSIBILITIES

• Ask the contract templates to the site for adapting to each study.
• Review study contract of the site, and assist with the contracts negotiations between the sites and sponsors
• Give support on the procedures for preparing, submitting and obtaining the site requirements, required initial local documents, amendments and approvals from the Independent Ethics Committees and Competent Authorities for each study.
• Extended knowledge of study documents and the procedures for preparation, maintenance and archiving of ISF, TMF and CMF.
• Translate documents.
• Follow up and update of LR databases about investigators /sites.
• Support in feasibility tasks for site’s selection.
• Attend team meetings.
• Compliance with the Quality Management System implemented in the company and collaborate in quality check process of the study documents if required.

JOB SKILLS

• Good knowledge of English language, good written and verbal skills (in English and country working language).
• Good capacity of teamwork, communication, and relationships with customers
• Above average interpersonal and organisational skills.
• Team spirit.
• Ethical behaviour.
• Willingness to work within the specific guidelines of the applicable quality system.