Sr. Clinical Research Associate II
Company: Labcorp
Location: Orlando
Posted on: January 27, 2023
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Job Description:
Job Description **Senior Clinical Research Associate II, FSP**
**USA - NC, SC, GA, FL, TN, AL, MS, AR, LA** Why settle for one
thing when you can have everything? Labcorp Drug Development gives
you the best two-for-one opportunity for career growth. Who doesn't
want twice the perks - working at one of the largest FSP CROs-and
partnering with one sponsor with a dedicated therapeutic focus. You
can have it all! Labcorp Drug Development gives you the best
opportunity for career growth. Our Energizing Purpose, Exceptional
People and Extraordinary Potential combined with collaborative and
proactive teams offer a great place for you to continue honing your
therapeutic skills and growing and excelling in new exciting
research. Our reach is global - extending to 60+ countries making
us one of the largest CROs. So, no matter where you are located on
the globe, we have an opportunity for you. We are seeking a Sr. CRA
II to be responsible for all aspects of study site monitoring and
management 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. **Additional responsibilities include:** + Organize and
make presentations at Investigator Meetings + Participate in the
development of protocols and Case Report Forms and clinical trial
reports as assigned + 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 as assigned + Negotiate study budgets with potential
investigators and assist the Covance legal department with
statements of agreements as assigned + Independently perform CRF
review; query generation and resolution against established data
review guidelines on Covance or client data management systems as
assigned by management + Travel, including air travel, may be
required and is an essential function of the job; prepare accurate
and timely trip reports; review progress of projects and initiate
appropriate actions to achieve target objectives + Conduct, report
and follow-up on Monitor Quality Control Visits (MQC) or Quality
Control Visits (CQC) when requested **Requirements:** + University
or college degree, or certification in a related allied health
profession from an appropriately accredited institution (e.g.,
nursing licensure). An equivalent amount of experience can be
substituted as appropriate. + Minimum of at least 3-4 years of
Onsite Clinical Monitoring experience. At least 1 year additional
experience in a related field is preferred." + Advanced site
monitoring; study site management; and registry administration
skills. + Ability to train and supervise junior staff; resolve
project related processes. + Thorough knowledge of ICH Guidelines
and understanding of local regulatory requirements + Thorough
knowledge of monitoring procedures; Basic understanding of the drug
accountability process + Valid Driver's License + Have a full
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; Ability to
work with minimal supervision + COVID-19 vaccination required
**Preferred Experience:** + Oncology experience preferred **Great
Benefits at Labcorp:** 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 **Labcorp is proud to be an Equal
Opportunity Employer:** As an EOE/AA employer, the organization
will not discriminate in its employment practices due to an
applicant's race, age, color, religion, sex, national origin,
sexual orientation, gender identity, disability or veteran status.
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Keywords: Labcorp, Orlando , Sr. Clinical Research Associate II, Other , Orlando, Florida
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