Responsible for all aspects of study site monitoring including routinemonitoring and close-out of clinical sites, maintenance of study files,conduct of pre-study and initiation visits; liaise with vendors; andother duties, as assigned.
• Responsible for all aspects of site management as prescribed in theproject plans
• General On-Site Monitoring Responsibilities:
• Ensure the study staff who will conduct the protocol have received theproper materials and instructions to safely enter patients into thestudy
• Ensure the protection of study patients by verifying that informedconsent procedures and protocol requirements are adhered to according tothe 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 byperforming the required monitoring tasks in an efficient manner,according to SOPs and established guidelines, including managing travelexpenses in an economical fashion according to Covance travel policy
• Prepare accurate and timely trip reports
• Manage small projects under direction of a Project Manager/Director asassigned
• Serve as lead monitor for a protocol or project and may assist inestablishing monitoring plans as assigned
• Review progress of projects and initiate appropriate actions toachieve target objectives
• Organize and make presentations at Investigator Meetings
• Report, write narratives and follow-up on serious adverse experiences
• Participate in the development of protocols and Case Report Forms asassigned
• Participate in writing clinical trial reports as assigned
• Interact with internal work groups to evaluate needs, resources andtimelines
• Act as contact for clinical trial supplies and other suppliers(vendors) as assigned
• Responsible for all aspects of registry management as prescribed inthe project plans
• Undertake feasibility work when requested
• Recruitment of potential investigators, preparation of EC submissions,notifications to regulatory authorities, translation of study-relateddocumentation, organization of meetings and other tasks as instructed bysupervisor as assigned
• Negotiate study budgets with potential investigators and assist theCovance legal department with statements of agreements as assigned
• Complete process of Serious Adverse Event (SAE) reporting, processproduction of reports, narratives and follow up of SAEs
• Independently perform CRF review; query generation and resolutionagainst established data review guidelines on Covance or client datamanagement systems as assigned by management
• Assist with training, mentoring and development of new employees, e.g.co-monitoring
• Co-ordinate designated clinical projects as a Local ProjectCoordinator (with supervision, if applicable), and may act as a localclient contact as assigned
• Perform other duties as assigned by management
