Sr. Clinical Research Associate II
Company: Labcorp
Location: Orlando
Posted on: January 25, 2023
|
|
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.
For more information about how we collect and store your personal
data, please see our Privacy Statement
(https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .
Keywords: Labcorp, Orlando , Sr. Clinical Research Associate II, Other , Orlando, Florida
Click
here to apply!
|