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