Site monitoring responsibility for clinical studies accordingto Covance Standard Operating Procedures, ICH Guidelines and GCP
Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Assures the implementation of project plans as assigned
Responsible for all aspects of study site monitoring including routine monitoring ond close-out of clinical sites, maintenance of study files, conduct of pre-study ond initiation visits; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plans
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 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
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
Internet 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 Visits (CQC) 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 Covance legal department with statements of agreements as assigned
Complete process of 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 Covance or client data management 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 Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Perform other duties as assigned by management
University/college degree (life science preferred), orcertification in a related allied health profession from anappropriately accredited institution, nursing certification,medical or laboratory technology
In lieu of the above requirement, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
Thorough knowledge of ICH Guidelines and GCP including abasic understanding of regulatory requirements in othercountries
Thorough understanding of the drug development process
Fluent in local office language and in English, both written and verbal
Minimum of 2 years of clinical research monitoringexperience (including prestudy,initiation, routine monitoring and closeout visits)
Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE