Clinical Research Associate II
Company: Labcorp Drug Development - USA
Location: Los Angeles
Posted on: March 20, 2023
|
|
Job Description:
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 o Ensure the study
staff who will conduct the protocol have received the proper
materials and instructions to safely enter patients into the study
o Ensure the protection of study patients by verifying that
informed consent procedures and protocol requirements are adhered
to according to the applicable regulatory requirements o 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 o 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 Travel,
including air travel, may be required and is an essential function
of the job 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 of new employees, e.g.
co-monitoring Coordinate 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 Qualifications: - University or college
degree, or certification in a related allied health profession from
an appropriately accredited institution (e.g., nursing licensure).
and a minimum of 2 years of Clinical Monitoring experience. -
Ability to monitor study sites independently according to
monitoring plan, project requirements, SOPs, and ICH GCP
guidelines. - Ability to work with minimal supervision. - Have
understanding of the Serious Adverse Event (SAE) reporting, process
production of reports, narratives and follow up of SAEs. - Good
planning, organization, and problem solving abilities. - Works
efficiently and effectively in a matrix environment. Preferred: -
One or more additional years of experience in a related field
(i.e., medical, clinical, pharmaceutical, laboratory, research,
data analysis, data management or technical writing) is preferred.
- Phase I monitoring experience. - Life Science or Nursing
qualification. US Pay Range: $105,000-$125,000 USD Benefits: All
job offers will be based on a candidate's skills and prior relevant
experience, applicable degrees/certifications, as well as internal
equity and market data. Regular, full-time or part-time employees
working 20 or more hours per week are eligible for comprehensive
benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K),
ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus
where applicable. For more detailed information, please click here
. Labcorp is proud to be an Equal Opportunity Employer: As an
EOE/AA employer, Labcorp strives for diversity and inclusion in the
workforce and does not tolerate harassment or discrimination of any
kind. We make employment decisions based on the needs of our
business and the qualifications of the individual and do not
discriminate based upon race, religion, color, national origin,
gender (including pregnancy or other medical conditions/needs),
family or parental status, marital, civil union or domestic
partnership status, sexual orientation, gender identity, gender
expression, personal appearance, age, veteran status, disability,
genetic information, or any other legally protected characteristic.
We encourage all to apply. For more information about how we
collect and store your personal data, please see our Privacy
Statement .
Keywords: Labcorp Drug Development - USA, Los Angeles , Clinical Research Associate II, Healthcare , Los Angeles, California
Click
here to apply!
|