Clinical Research Associate II - Unblinded
USA - Florida
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.
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 FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.
We are seeking an Unblinded Clinical Research Associate, a specialized role, which primarily focuses on drug accountability, at the site level, across a range of protocols and therapeutic areas.
Additional responsibilities include:
Organize and make presentations at Investigator Meetings
Participate in the development of protocols and Case Report Forms 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
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 1 year of Onsite Clinical Monitoring experience along with at least 1 year total in clinical research experience is required
Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
Thorough knowledge of monitoring procedures; Basic understanding of the drug accountability process
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
Valid Driver's License
Great Benefits at Labcorp:
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:
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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- Case Report Forms
- Clinical Research
- Financial Management
- Ich Guidelines