Clinical Operations

BE PART OF OUR TEAM DISCOVERING CURES

Here, with us, you will have the opportunity to help save and enhance lives worldwide. You will have a chance to collaborate your creativity, digital competence, or scientific talent to work with various colleagues who pursue and provide hope to countless individuals suffering from some of the most challenging diseases. Our team is constantly evolving, so if you are intellectually interested, join us and start making a difference.

Who we are

Central & Eastern Europe Research Institute (CEERI) is a Clinical Research Organization (CRO) and a Site Management Organization (SMO) that supports clinical research studies across countries in central and eastern Europe as well as the Balkans.

We support pharmaceutical companies in developing clinical research studies across our medical sites. We have a large team of Principal Investigators who are GCP (Good Clinical Practice) trained with extensive experience in clinical trials in almost all therapeutic areas and who have access to large patient populations.

CEERI is expanding its clinical operation in several studies in North Africa and looking for motivated individuals to support short, mid, and long-term research projects in different capacities, from short-term project-based internships to full-time managerial roles.

Job Description

We are seeking candidates to support short, mid, and long-term research projects at different capacities, from short-term project-based internships to full-time managerial roles. We encourage people from all levels of experience, applicants with healthcare backgrounds, or plans to join the healthcare industry to apply. Candidates are encouraged to define their short-term and long terms goals so that the HR team can suggest the right track.

Basic Qualifications

• • Proficiency in English
• • University or college degree or certification in a related allied health profession from an appropriately accredited institution
• • Understanding of international projects,
• • Proficiency in Microsoft Office Solutions
• • Valid Driver’s License

Assets

• • Experience in Clinical Monitoring/Project Management experience is preferred
• • Knowledge of ICH Guidelines and GCP, including a basic understanding of regulatory requirements in Tunisia
• • Understanding of the drug development process
• • Experience in clinical research
• • Thorough understanding of the healthcare industry

Responsibilities

• • Willing to participate in relevant training, if necessary
• • Responsible for the delivery and oversight of all clinical study milestones
• • Developing and assistance in study management plans and ensuring consistent use of study tools, training materials, and compliance with SOPs (Standard Operating Procedures)
• • Responsible for all aspects of study site monitoring and management, including routine monitoring and close-out of clinical sites, maintenance of study files, the conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• • Evaluates and provides recommendations on optimal TMF (Trial Master File) setup. Drives the TMF set-up, structure, and completeness reports.
• • Presents monthly TMF status, risks, issues, and associated actions for assigned projects
• • Organize and make presentations at Investigator Meetings
• • Recruitment of potential investigators, preparation of MOH (Ministry of Health) and EC (Ethics Committee) submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor as assigned
• • Negotiate study budgets with potential investigators and assist with statements of agreements as assigned
• • Independently perform CRF (Case Report Form) review, query generation, and resolution against established data review guidelines of client data management systems