Job Description - Clinical Research Coordinator

Alternative Job Titles

Study Site Coordinator                Clinical Research Nurse
Clinical Trial Coordinator              Clinical Trial Officer
Research Coordinator                  Research Nurse

Description

The Clinical Research Coordinator provides a vital link between investigative site and sponsor team. This on-site position includes a variety of tasks with a support and practical base. The CRC is positioned within the research team together with physicians and scientists, with the potential to be involved in the development stages of the protocol through to the completion of the studies.

Qualifications

A CRC candidate varies dependent on the job profile, however, the most common qualifications which are required are a BS/BA in a (bio-) medical field or a nursing degree. The candidate should possess knowledge and insight into legal and regulatory matters concerning clinical research. Excellent English and local language skills; both oral and written.

Competencies

• Proactive attitude
• Open and clear communicator
• Understands the needs of others
• Coordination and planning of budgets, people and time management
• Recognise potential obstacles and work to resolve them within set timelines
• Conscientious and precise delivery of work even when under pressure
• Flexible and open to change

Tasks   

• Protocol evaluation and feasibility including budget evaluation
• Clinical trial preparation involving the planning, assembling and instruction of the trial team, development and evaluation of patient information and informed consent forms and patient recruitment
• Regulatory and ethical submissions and procedures and communicating with relevant authorities
• Implementation of the clinical trial from initiation through the stages of development documents, SOPs, tools, organisation facilities and licences
• Recruitment and co-ordination of the trial subjects covering informed consent, screening and inclusion of the subjects adhering to safety and compliance issues
• Co-ordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and product accountability
• Data collection and management, collection of source documents, using and developing CRFs, registration and management AEs, filing and archiving, managing monitoring visits, dealing with queries
• Close-out of the clinical trial, contributing to research article, audit preparation, trial closure, communication with authorities and other disciplines involved, assisting in the final study report and completing financial obligations.
  
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