1) 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; liaise with vendors; and other duties, as assigned 2) Responsible for all aspects of site management as prescribed in the project plans 3) General On-Site Monitoring Responsibilities: 4) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study 5) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements 6) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review 7) Monitor data for missing or implausible data 8) Ensure the resources of the Sponsor and Company 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 Company travel policy 9) Ensure audit readiness at the site level 10) Travel, including air travel, may be required and is an essential function of the job. 11) Prepare accurate and timely trip reports 12) Interact with internal work groups to evaluate needs, resources and timelines 13) Act as contact for clinical trial supplies and other suppliers (vendors) as assigned 14) Responsible for all aspects of registry management as prescribed in the project plans 15) Undertake feasibility work when requested 16) participate in and follow-up on Quality Control Visits (QC) when requested 17) 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 18) Assist Senior CRA with managing investigator site budgets 19) Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs 20) Independently perform CRF review; query generation and resolution against established data review guidelines on Company or client data management systems as assigned by management 21) Assist with training, mentoring and development of new employees, e.g. co-monitoring 22) Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned 23) Perform other duties as assigned by management
Experience:
Minimum Required: 61 Six (6) months experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.) 61 Basic understanding of Regulatory Guidelines 61 Ability to work within a project team 61 Good planning, organization and problem solving skills 61 Good computer skills with good working knowledge of a range of computer packages 61 Works efficiently and effectively in a matrix environment 61 Valid Driver's License
Education/Qualifications/Certifications and Licenses
Minimum Required: 61 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. 61 Basic knowledge of Regulatory Guidelines 61 Basic understanding of the clinical trial process 61 Fluent in local office language and in English, both written and verbal
