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| CRA |
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Designation: Clinical Research Associate
Department: Clinical Operations
Location: France, Italy, Belgium, Hungary and Austria
Qualification: Minimum B.A.or B.S., preferably in a health related field
Experience: Atleast 3 years of field monitoring experience in a pharma/
biotech/ CRO environment
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| Job Responsibilities: |
- Perform routine monitoring visits as per the
monitoring plan (source document verification,
drug accountability, Case Report Form
collection, etc.) and write monitoring reports
per Veeda specifications. Follow ¬upon action
items as needed.
- Ensure that Serious Adverse Events are
appropriately reported to Veeda Oncology
Pharmacovigilance or the Sponsor’s
Pharmacovigilance Department inatimely fashion.
- Follow¬upon Serious Adverse Events in
cooperation with the Pharmacovigilance
Department.
- Assume primary responsibility for site
management and as such respond to study related
questions from sites.
- Assist in writing monitoring plans,
monitoring checklists, monitoring tools,
templates for visit reports (sitequalifications,
site initiations, interim monitoring visits and
closeouts), letters to the investigators and
other study related documents.
Generate study tools for sites and monitoring
team.
- At the direction of the Project Manager,
conduct feasibility studies and assist in
investigator identification.
- Coordinate efforts with counter parts outside
of Europe for seamless monitoring of global
trials, as required.
- Prepare SIV Power Point presentations.
- Proactively identify potential issues, notify
Project Manager and develop strategies to
address such issues.
- Assist Director of European Clinical
Operations and PM with other clinical and
business activities such as Investigators
’Meetings, bid defense meetings, tracking of
metrics and other duties asassigned.
- Develop and maintain excellent relationship
with clients and site personnel to provide
exemplary customer service
- Organize and conduct conference calls; write
and distribute minutes as needed.
- Establish and maintain effective
communications with other team members.
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| Essential Skills/Knowledge: |
- At least 3 years field monitoring experience
in a pharma/ biotech/ CRO environment
- Atleast 2 years oncology monitoring
experience
- Customer service orientation
- In-depth knowledge of medical terminology and procedures, particularly oncology-related
- Excellent verbal and written skills in the English language
- Flexible with regard to work assignments,
able to work on multiple tasks/ projects and
prioritize workload
- Attention to detail
- Ability to take initiative and be proactive
- Ability to work independently, but also able
to be a team member in a matrix environment
- Strong interpersonal skills
- Computer literate – proficient in MS-based applications such as Word, Excel and PowerPoint
- Willingness to travel
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Closing Date: 10/08/10
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