Clinical Research Associate II, FSP Located in California
Why settle for one thing when you can have everything. Labcorp Drug Development gives you the best opportunity for career growth. O ur 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 not matter where you are locating on the globe we have an opportunity for you.
We are seeking a CRA I I to be r esponsible 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 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.
- COVID-19 vaccination required
- M inimum 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 understan ding 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
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:
• Life, STD/LTD
• 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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