Clinical Research Associate Ii

Clinical Research Associate
Remote USA - SE & West
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com
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 a CRA 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
• Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
• Participate in the development of protocols and Case Report Forms 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
• 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

Requirements

• COVID-19 vaccination required
• 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 leas

The Principal Biostatistician at Labcorp is a Lead role. This is a home-based opportunity to work with multiple Sponsors across several therapeutic areas in all phases of medical device trials, including diagnostics and imaging. The Principal Biostatistician will be leading projects, mentoring junior members of the department, and serving as a technical advisor. The position offers an excellent support network with access to Labcorp Drug Development’s statistical consultants, flexible working solutions, and the opportunity to progress your career. If you are looking to strengthen your Lead expertise within a varied and dynamic environment, then this is a fantastic opportunity.
Job Primary Functions

• Develop the statistical sections of the protocol for medium to high complexity studies
• Attend bid defense meetings for medium to high complexity studies in order to win new business
• Perform Lead Biostatistician role on medium and high complexity studies, providing statistical oversight and attending relevant project meetings
• Effectively communicate statistical concepts and results to audiences with various statistical knowledge
• Preparation of Statistical Analysis Plans (including mock TFL shells) for medium and high complexity studies
• Perform project management activities for identified projects including resource planning, timelines and milestone management
• Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
• Conduct overall statistical review of TFLs for complex studies prior to client delivery
• Mentor junior biostatisticians; serve as a technical advisor to departmental employees
• Provide statistical input and review the CSR for complex studies
• Represent the department during audits

Education Required

• Master’s degree, equivalent, or higher in Biostatistics, Statistics, or related field

Qualifications

• SAS® proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis required
• A good knowledge of the overall clinical trial process
• Experience with medical device studies preferred
• Previous experience of leading studies as a Biostatistician in a CRO or at a medical device or pharma company required
• 10+ years of overall experience, or an equivalent combination of education and experience
• Experience with preparation of Statistical Analysis Plans, analysis, reporting, etc.
• Ability to program in a statistical software package other than SAS® preferred
• Some knowledge of CDISC requirements preferred
• Ability to effectively communicate statistical concepts, both to internal and external stakeholders

Labcorp Is Proud To Be An Equal Opportunity Employer
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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