Job Description

Work schedule must be flexible based on time zones for project needs. This Remote contract position is part of the Regulatory and Clinical Affairs organization. This position ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements (domestically and internationally) and is submitted to the FDA in a complete, accurate, and timely manner for approvals in support of the business units. Your work will impact the quality of the FDA submissions and help secure the necessary approvals for our products to be marketed and reach the patients who will ultimately benefit from these diagnostics. What will you do? The primary role of this position is targeted toward clinical studies support and study site management. In this role the primary responsibilities include: •Coordinating and conducting activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics •Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements •Collect all clinical study essential documents •Ensure that CRO activities and timelines are in coordination with project requirements •Implement and document communication with CRO and laboratories to ensure project progress •Real time escalation of Clinical studies issues to Clinical Study Managers •Ensure compliance with company SOPs •Assist in performing remote lab assessment visits. Education •A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. •Working knowledge of Good Clinical Practices is required. •Certification as a Clinical Research Professional (CCRP) is a plus •If certification is not in place, class work/ course work in Good Clinical Practices is required.Experience •Minimum of 2 years working in the In Vitro Diagnostic or Medical Device Industry. In Vitro diagnostic experience is a plus. •A Minimum of 2 years demonstrated experience in supporting the management of in house and/or external clinical studies. •Experience working with multi-functional project teams is required. •Computer literacy, including spreadsheet, database and word processing applications required.Knowledge, Skills, Abilities •Ability to adjust schedule in order to work with multiple time zones •Candidate must be an independent professional who proactively communicates frequently and effectively. •Must be comfortable working on projects where the project and its team members may be located at other sites. •Should be at ease with direct communication with internal project team members and external CROs and •Should be organized and able to work to on multiple projects with tight deadlines. •High energy level; positive attitude; works well under stress; assertive and effective communicator. •Hands-on, action-oriented, and able to implement effectively. Della Infotech

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