Essential Job Duties:

• Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assigned
• Responsible for aspects of registry management as prescribed in the project plans
• General On-Site Monitoring Responsibilities: o Assist Senior CRAs and CRA-2 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
  • Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. On-site Routine Monitoring Visits should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management).
  • 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 Covance 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 Covance travel policy
• Travel, including air travel, may be required as per essential job functions.
• Prepare accurate and timely trip reports
• Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management
• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
• Provide coverage for clinical contact telephone lines, as required
• Update, track and maintain study-specific trial management tools/systems
• Generate and track drug shipments and supplies, as needed
• Track and follow-up on serious adverse events as assigned

Experience: Minimum Required:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
• a minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
• Ability to work within a project team
• Good planning, organization and problem solving abilities
• Good communication skills, oral and written
• Good computer skills
• Works efficiently and effectively in a matrix environment
• Fluent in local office language and in English, both written and verbal

Education/Qualifications Minimum Required:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
• A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
• Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements
• Basic understanding of the clinical trial process
• Valid Driver\xe2\x80\x99s License

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 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.