Site Management Assistant

Job Overview:

Job Summary:

Provide support for projects according to Covance Standard Operating Procedures (SOPs), Project-specific Controlled Documents, FDA and ICH Guidelines and GCPs Perform investigative site recruitment/feasibility, essential document collection and review Provide in-house site management Maintain tracking systems for projects Assist in centralized monitoring responsibilities when necessary as assigned by supervisor Assist in the review of study data in accordance with Data Management Plans and other applicable plans

Essential Job Duties:  Ensure compliance with Covance SOPs, Project-specific Controlled Documents, FDA and ICH guidelines, GCPs, and GPPs for clinical conduct in all aspects of daily work including adherence to Project Plans, Data Management Plans, Site Management Plan, Monitoring Conventions, etc. Assist with the facilitation of site evaluation and recruitment including, collection and review and close out of required critical documents from sites (including submissions and notifications to Institutional Review Boards or Ethics Committees (where applicable)) by creating, updating, tracking, and maintaining study-specific trial management files, tools, and systems. Support investigators in fulfilling their obligations with regard to submission according to applicable local, regulatory, and IRB/IEC requirements. Assist training with sites on web-based applications; including but not limited to: Web-ex and Investigator Meetings. Manage study sites to ensure adherence to study design . Maintain regular contact with study sites via telephone (in-coming and out-going calls), fax, email, and newsletters. Maintain timely documentation of site contacts in defined project system. Act as primary point of contact for assigned study sites and retain primary responsibility for the resolution of all site issues. Manage subject screening/enrollment, Data Collection Tool retrieval, study supply, and query distribution to/retrieval from assigned study sites. Assist with administrative duties including preparation of status reports, payments to sites and participation in regular project team meetings including preparation and distribution of meeting minutes. Facilitate communications with vendors and assist with the management of study supplies. Assist with the review study data in accordance with Monitoring Plan, Site Management Plan, Data Management Plans and applicable (SOPs, etc) to identify data trends, data inconsistencies, and erroneous, missing, incomplete, or implausible data through the aggregate review of study data by patient, site, and/or project. Ensure accurate and expeditious safety reporting in accordance to federal guidelines and sponsor and program requirements. General Monitoring Responsibilities – Centralized: Assist in the initiation, monitoring and close out of Investigator sites via phone including review of Case Report Forms. Review site information and communicate with sites to resolve data discrepancies. Perform other duties as assigned by management. Education/Qualifications:Required: University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). In lieu of the above requirement, candidates with one (1) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered Fluent in local office language and in English, both written and verbal Experience:Required: Basic understanding of biology and biological processes. Good organizational and time management skills. Good communication skills, oral and written. Work efficiently and effectively in a matrix environment Exhibit general computer literacy. Ability to work within a project team Preferred: One (1) or more years of experience in a related field, (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing).