Clinical Research Associate II, FSP
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:
Labcorp is proud to be an Equal Opportunity Employer:
- Life, STD/LTD
- Paid time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable
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.
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