Senior Clinical Research Associate (Florida)

Company: LabCorp
Location: Daytona Beach
Posted on: March 13, 2023

Job Description:

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. This is a remote role, but candidates must reside in Florida Required Travel: 60% (8-10 days on site a month) Responsible for all aspects of study site monitoring 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. General On-Site Monitoring Responsibilities:

• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
• Monitor data for missing or implausible data
• Ensure the resources of the Sponsor and Labcorp are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy
• Ensure audit readiness at the site level
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare accurate and timely trip reports
• Manage small projects under direction of a Project Manager/Director as assigned. Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned
• Review progress of projects and initiate appropriate actions to achieve target objectives
• Organize and make presentations at Investigator Meetings
• Participate in the development of protocols and Case Report Forms as assigned
• Participate in writing clinical trial reports as assigned
• Interact with internal work groups to evaluate needs, resources and timelines
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Conduct, report and follow-up on Quality Control (QC) visits when requested
• 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 Labcorp legal department with statements of agreements as assigned
• Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp or client data management systems as assigned by management
• Assist with training, mentoring and development of new employees, e.g. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
• Perform other duties as assigned by management.Qualifications:
  • University or college degree, or certification in a related allied health profession from an appropriate accredited institution (e.g. nursing license)
  • a minimum of 2 years clinical trials or site management experience (e.g. study coordinator, project coordinator, project specialist, study start-up).US Pay Range: $115,000-$135,000 USDBenefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. 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. For more detailed information, please click here . 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. For more information about how we collect and store your personal data, please see our Privacy Statement .

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