- Maintain updated patient database plus regular site contact and visits.
- Â• Translate protocol requirements into the sitesâ€™ daily routine and develop site specific recruitment strategy based on local resourcing, infra-structure and recruitment potential.
- Â• Collaborate and exchange information with site staff on a regular basis.
- Â• Synergistic communication and interaction with in-house Clinical Monitoring and onsite Clinical
- Research associates (as appropriate) on a regular basis.
- Â• Identify opportunities for the CEM service to be offered, through an appreciation of site needs, awareness of enrolment needs, information arising out of site meetings.
- Â• Contribute to the development and maintenance of an effective patient database.
- Â• Review patient notes, select and present high quality patients to fulfill enrolment needs.
- Â• Review site screening records to identify potential subjects. Work with local centres to facilitate patient referral process to main centres.
- Â• Supply (and coordinate) information for brochures, newsletters, proposals and advertisements concerning the study recruitment.
- Â• Organise and conduct spirometry training and co-ordinate other appropriate trainings in cooperation with site staff to ensure continuous development.
- Â• Undertake the full range of duties relevant to the CEM to ensure that performance meets and/or exceeds the enrolment for the study.
- Â• Maintain a positive, results-oriented work environment, building partnerships and modelling teamwork, communicating to the site staff in an open, balanced and objective manner.
- Â• Fixed period of support to the data cleaning activities
- Degree level or equivalent nursing background
- Â• Current study nurses with COPD background or respiratory therapists
- Â• Spirometry Technicians/Lung Function Technicians
- Â• CRAs with monitoring experience with COPD studies
- Â• Knowledge of the Pharmaceutical / Clinical Research industries
- Â• Preferred experience in:
o Spirometry training
o Dealing with low recruiting sites
o Handling data queries and data clean up
- Â• Excellent interpersonal, written and verbal communication skills including strong influencing and persuasion skills
- Â• Personalities who are able to lead site staff and to assure that sites have accurate understanding of the value of protocol.
- Â• Good understanding of the healthcare systems management of (COPD) patients in the area or community in which they are located.
- Â• Willingness to take initiative to develop novel approaches and build new relationships between all parties involved in the management of these patients in order to facilitate their participation in the study.
- Â• Proficiency in Microsoft Word, Excel, power-point and Outlook.
- Â• Patient focused and recruitment awareness, and to be able to interact effectively.
- Â• Flexible attitude to work assignments and travel extensively within specified country.
- Â• Ability to manage multiple and varied tasks with enthusiasm and prioritise workload with attention to detail.
- Â• ICH/GCP trained.