I CON
Clinical Research Associate II
Position
Summary
4+
years of experience in monitoring
hands-on
experience in Oncology Trials & Therapeutic area
Required
days on-site - 8.5 to 12 Days per month.
PAN
India Travel involved.
Job
Description :
Recognize,
exemplify and adhere to ICON"s values which center around our commitment
to People, Clients and Performance.
As a
member of staff, the employee is expected to embrace and contribute to our
culture of process improvement with a focus on streamlining our processes
adding value to our business and meeting client needs.
Ability
and willingness to travel at least 60% of the time.(international and domestic
: fly and drive)
Expert
knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations.
Familiarity
with ICON systems .
Maintain
timelines . Ensure accuracy and completeness of data entered into ICON systems.
Recruitment
of investigators .
Independent
and proactive coordination of all the necessary activities required to set up
and monitor a study ,
Including
but not limited to the following :
Identify
investigators.
Help
when requested , in preparation of regulatory submissions .
Design of patient
information sheets and consent forms .
Ensure
timely submission of protocol/consent documents for ethics/IRB approval. Pre
study/placement and initiation visits. Conduct regular monitoring visits in
accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as
appropriate
Maintain
all files and documentation pertaining to studies . Motivate investigators in
order to achieve recruitment targets. Complete accurate study status reports.
Ensure
the correct storage of drugs and the diligent account of all drugs in
accordance with SOPs.
Keep
the Project Manager regularly informed.
Process
case record forms to the required quality standards and timelines . Deal with
sponsor generated queries in a timely manner.
Ensure
the satisfactory close-out of investigator sites .
Participate,
if requested, in the preparation of and review of study documentation , e.g.
draft protocols, draft CRFs, monitoring guidelines and elements of final
report.
Participate
in feasibility studies for new proposals as required. Ensure correct archiving
of files on completion of a study .
Maintain
patient and sponsor confidentiality .
Assume
additional responsibilities as directed by the Project Manager.-
lnvestigational
Products (IPs) stored and managed by the site:
Ensure
storage conditions and acceptable supplies are provided
Ensure
IPs are supplied only to eligible patients
Ensure
IP receipt, use and return are controlled and documented
Ensure
disposition of unused IP comply with regulatory requirement and are in
accordance with the sponsor.
Act
in a lead role on a study assuming additional responsibilities as
detailed/documented by the Project Manager if appropriate .
Participate
in data listing reviews, as applicable .
Responsible
for cost effectiveness
Participate
in training and mentoring new staff up to Clinical Research Associate level as
appropriate.
Assist
with marketing the company if and when appropriate . Other duties as assigned .
Technical
and competency selection:
When
you spot an opportunity you're interested in and submit an application, one of
our Talent Acquisition Specialists will contact you to evaluate your
suitability for this position, as well as for other openings within the
business. The evaluation will look at your technical skills and your
competencies - for example, delivering excellence.
Interview
After
this, we'll let you know if we'll be progressing with your application. If you
have been successful at this stage, we will talk you through a telephone
interview. This will then be followed by an interview with our Hiring Manager,
either face to face or by tele-conference.
Offer
If
you're successful, we will notify you with details of the offer, talk you
through our culture and values, answer any questions you may have - and above
all, welcome you to the ICON team.
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