Site Management Associate II (USA remote)

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 Develop and/or maintain tracking systems for projects Conduct centralized monitoring responsibilities when necessary as assigned by supervisor Review study data in accordance with Data Management Plans and other applicable plans

Duties and Responsibilities : Ensure compliance with Covance SOPs, Project-specific Controlled Documents, FDA and ICH guidelines GPPs, and GCPs for clinical conduct in all aspects of daily work including adherence to Project Plans, Data Management Plans, Site Management Plan, Monitoring Conventions, etc. Perform 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 Oversee and conduct training with sites on web-based applications; including but not limited to:  Web-ex and Investigator Meetings Independently manage study sites to ensure adherence to the 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 retains primary responsibility for the resolution of all site issues Independently manage subject screening/enrollment, Data Collection Tool retrieval, study supply, and query distribution to/retrieval from assigned study sites Assist in development of phone scripts, questionnaires, study site materials and other project specific tools Facilitate the preparation of status reports, payments to sites and participation in regular project team meetings including review and distribution of meeting minutes Oversee and maintain communications with vendors and facilitate the management of study supplies Manage investigator site budgets Independently 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 Support mentoring of junior staff members General Monitoring Responsibilities – Centralized: Initiate, monitor and close out 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 three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements Good understanding of the clinical trial process Fluent in local office language and in English, both written and verbal Experience:Required:Minimum of two (2) years clinical research experience of centralized and/or on-site monitoring Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow up SAEs Good planning, organization and problem solving abilities Ability to work with minimal supervision Good communication and interpersonal skills Good analytical and negotiation skills Computer competency Works efficiently and effectively in a matrix environment Ability to work within a project team Preferred:      One (1) or more additional years of experience on site monitoring