Senior Clinical Research Associate II (2229584)
Why settle for one thing when you can have everything. 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 not matter where you are locating 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
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
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
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.