Senior Clinical Research Associate I

Senior Clinical Research Associate I - FSPUSA - NortheastOncologyWhy settle for one thing when you can have everything?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 no matter where you are located on the globe, we have an opportunity for you!We are seeking a Senior Clinical Research Associate I to be responsible for all aspects of study site monitoring and management including routine monitoring and close-out of clinical sites; maintain study files; conduct 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

Requirements: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 2 years of onsite Clinical Monitoring experience

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

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

Preferred Experience:At least 1 year of additional experience in a related field is preferred

Great Benefits at Labcorp:Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:Medical

Dental

Vision

Life, STD/LTD

401(K)

ESPP

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.For more information about how we collect and store your personal data, please see our Privacy Statement (https://www.labcorp.com/hipaa-privacy/web-privacy-policy) .