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Clincal Research AssociateOncology ContractCentral Region - Novella Clinical

Location
Green Bay, WI

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Clincal Research Associate,Oncology (Contract,Central Region) - Novella Clinical
IQVIA

Green Bay
WI
Job #682340307
Description:
BASICFUNCTIONS:
Participates
in the preparation and execution of Phase I-IV clinical trials. Oversees the
progress of clinical investigations by conducting pre-study, initiation,
interim and close out visits to sites. Monitors clinical trials in accordance
with Good Clinical Practices and procedures set forth by Novella and sponsors.
Works closely with the Clinical Trial Manager to ensure all monitoring
activities are conducted according to study requirements.
ESSENTIALJOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
·
Participates
in the investigator recruitment process. Performs initial qualification visits
of potential investigators. Evaluates the capability of the site to
successfully manage and conduct the clinical study, both clinically and
technically
·
Assists in
the preparation and review of protocols, eCRFs, study manuals, and other study
documents as requested by Clinical Trial Manager
·
Works with
the Study Start-up Group to coordinate activities with the site in preparation
for the initiation of studies. Obtains and reviews regulatory documentation for
successful implementation, monitoring, and evaluation of clinical trials. Works
with Study Start-up Group and site staff to obtain regulatory (IRB/IEC)
approval of study specific documents
·
Performs
study initiation activities, reviewing with the site personnel the protocol,
regulatory issues, study procedures, and provides training on completion of the
eCRF; monitoring activities and study close-out activities
·
Trains site
staff on the EDC system and verifies site computer system
·
Conducts
periodic site file audits to ensure compliance with GCPs and Novella standard
operating procedures
·
Assures
adherence to Good Clinical Practices, investigator integrity, and compliance
with all study procedures through on-site monitoring visits. Performs
validation of source documentation as required by sponsor. Prepares monitoring
reports and letters in a timely manner using approved Novella/sponsor forms and
reports
·
Documents
accountability, stability and storage conditions of clinical trial materials as
required by sponsor. Performs investigational product inventory.
Ensures return of unused materials to designated location or verifies
destruction as required
·
Reviews the
quality and integrity of the clinical data through (1) in house review of
electronic CRF data and (2) on-site source verification. Works with sites to
resolve data queries
·
Serves as
primary contact between Novella and investigator; coordinates all
correspondence; ensures timely transmission of clinical data with the study
site and technical reporting, as requested
·
Assists with,
attends, and may present at Investigator Meetings for assigned studies
·
Performs
study close-out visits
·
Serves as
mentor for more junior CRAs as well as new CRAs to the project
·
May conduct
field training and assessment of CRA Is and CRA IIs
·
Authorized to
request site audits for reasons of validity
·
Performs
other duties as requested
KNOWLEDGE,SKILLS AND ABILILTIES:
·
Strong
knowledge of clinical research process and medical terminology.
·
At least four
years experience in monitoring clinical trials preferred.
·
Excellent
written and verbal communication skills to express complex ideas to study
personnel at research and clinical institutions.
·
Excellent
organizational and interpersonal skills.
·
Ability to
interact with all levels of staff to coordinate/execute study activities.
·
Ability to
handle several priorities within multiple, complex clinical trials.
·
Ability to
reason independently and recommend specific solutions in clinical settings.
·
Able to
mentor other CRAs on project team and co-monitor as required.
·
Understanding
of basic data processing functions, including electronic data capture.
·
Understanding
of current GCP/ICH guidelines applicable to the conduct of clinical research.
·
Able to
qualify for a major credit card.
·
Valid
driver’s license; ability to rent automobile.
·
Willingness
and ability to travel domestically and internationally, as required.
CRITICALJOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
·
Ability to
travel domestically and internationally.
·
Very limited
physical effort required to perform normal job duties.
Qualifications:
MINIMUMRECRUITMENT STANDARDS:
·
BS/BA (or equivalent) in one of the life sciences
with a minimum of 4 years of monitoring experience or equivalent amount of
education/experience.
·
Must possess
excellent verbal and written communication, interpersonal and organizational
skills.
·
Requires an ability
to work independently, prioritize, and work within a matrix team environment.
·
Computer
literacy and knowledge of electronic data capture preferred.
·
Must be able
to travel domestically and internationally 50-75%.
EEO Minorities/Females/Protected Veterans/Disabled
Primary Location:
USA-Tennessee-Nashville
Other Location(s):
USA-Wisconsin-Milwaukee, USA-Kansas-Kansas City, USA-Wisconsin-Green Bay, USA-Wisconsin-Madison, USA-Missouri-Kansas City, USA-Illinois-Chicago
Updated 06/12/2018

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