Responsibilities:
- Responsible
for all aspects of study site monitoring including routine monitoring and
close-out of clinical sites, maintenance of study files, conduct of
pre-study and initiation visits; liaise with vendors; and other duties, as
assigned - Responsible
for all aspects of site management as prescribed in the project plans - General
on-site monitoring responsibilities - Ensure
the study staff who will conduct the protocol have received the proper
materials and instructions to safely enter patients into the study - Ensure
the protection of study patients by verifying that informed consent
procedures and protocol requirements are adhered to according to the
applicable regulatory requirements - Ensure
the integrity of the data submitted on Case Report Forms (CRFs) or other
data collection tools by careful source document review. Monitor data for
missing or implausible data - Ensure
the resources of the Sponsor and Covance are spent wisely by performing
the required monitoring tasks in an efficient manner, according to SOPs
and established guidelines, including managing travel expenses in an
economical fashion according to Covance travel policy - Prepare
accurate and timely trip reports - Responsible
for all aspects of registry management as prescribed in the project plans - Undertake
feasibility work when requested - Recruitment
of potential investigators, preparation of EC submissions, notifications
to regulatory authorities, translation of study-related documentation,
organization of meetings and other tasks as instructed by supervisor - Negotiate
study budgets with potential investigators and assist the Covance legal
department with statements of agreements as assigned - Complete
Serious Adverse Event (SAE) reporting, process production of reports,
narratives and follow up of SAEs - Independently
perform CRF review; query generation and resolution against established
data review guidelines on Covance or client data management systems as
assigned by management - Assist
with training, mentoring, and development of new employees, e.g. co-monitoring - Co-ordinate
designated clinical projects as a Local Project Coordinator (with
supervision, if applicable), and may act as a local client contact as
assigned - Perform
other duties as assigned by management
Requirements:
- University/
college degree (life science preferred), or certification in a related
allied health profession from an appropriately accredited institution - Experienced
in clinical research monitoring - Ability
to monitor study sites according to protocol monitoring guidelines, SOPs,
GCP and ICH Guidelines - Have
a full understanding of the Serious Adverse Event (SAE) reporting, process
production of reports, narratives and follow up of SAEs - 12
Months contract position
Interested
applicants, please send in your resume to fenny.trisnawati@covance.com
applicants, please send in your resume to fenny.trisnawati@covance.com
