Clincal Research Associate,Oncology (Contract,Central Region) - Novella Clinical
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:
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
the preparation and review of protocols, eCRFs, study manuals, and other study
documents as requested by Clinical Trial Manager
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
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
staff on the EDC system and verifies site computer system
periodic site file audits to ensure compliance with GCPs and Novella standard
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
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
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
primary contact between Novella and investigator; coordinates all
correspondence; ensures timely transmission of clinical data with the study
site and technical reporting, as requested
attends, and may present at Investigator Meetings for assigned studies
study close-out visits
mentor for more junior CRAs as well as new CRAs to the project
field training and assessment of CRA Is and CRA IIs
request site audits for reasons of validity
other duties as requested
KNOWLEDGE,SKILLS AND ABILILTIES:
knowledge of clinical research process and medical terminology.
At least four
years experience in monitoring clinical trials preferred.
written and verbal communication skills to express complex ideas to study
personnel at research and clinical institutions.
organizational and interpersonal skills.
interact with all levels of staff to coordinate/execute study activities.
handle several priorities within multiple, complex clinical trials.
reason independently and recommend specific solutions in clinical settings.
mentor other CRAs on project team and co-monitor as required.
of basic data processing functions, including electronic data capture.
of current GCP/ICH guidelines applicable to the conduct of clinical research.
qualify for a major credit card.
driverâ€™s license; ability to rent automobile.
and ability to travel domestically and internationally, as required.
CRITICALJOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
travel domestically and internationally.
physical effort required to perform normal job duties.
BS/BA (or equivalent) in one of the life sciences
with a minimum of 4 years of monitoring experience or equivalent amount of
excellent verbal and written communication, interpersonal and organizational
Requires an ability
to work independently, prioritize, and work within a matrix team environment.
literacy and knowledge of electronic data capture preferred.
Must be able
to travel domestically and internationally 50-75%.
EEO Minorities/Females/Protected Veterans/Disabled
USA-Wisconsin-Milwaukee, USA-Kansas-Kansas City, USA-Wisconsin-Green Bay, USA-Wisconsin-Madison, USA-Missouri-Kansas City, USA-Illinois-Chicago