Position Description:

A successful candidate, as a member of the Clinical Affairs group, will work collaboratively with multi-disciplinary teams to support the development of new assay test systems and laboratory services in the areas of prenatal, neonatal and child health.  This role will initiate, coordinate, and take responsibility for developing supporting documents (such as protocol, informed consent, case report forms, etc) related to study conduct, including source documentation, monitoring and study guidelines, and training materials to assure compliance with regulatory requirements and alignment with study objectives.  Responsible for implementing and facilitating clinical trials at multiple external sites, ensuring project schedules, risks and issues are managed appropriately.  Conduct on-site monitoring visits in accordance with Federal regulations, Good Clinical Practices, ICH guidelines and standard operating procedures.   Establish professional rapport and frequent communication with investigational site personnel.  Assist in the review of clinical data and generation of study reports for US regulatory submission.  Has the ability to work as part of a global cross-functional team, as well as independently, manage multiple projects and adapt to changing priorities.  This position will report to the Genetic Screening Director of Regulatory and Clinical Affairs.

Education and Experience:

·          BS/MS degree in scientific or medical discipline

·          Minimum of 4 years of experience in clinical trial monitoring, IVD studies strongly preferred

·          Knowledge of clinical research procedures and FDA Good Clinical Practices

·          Excellent organizational and communication (written and oral) skills with attention to detail

·          Ability to travel extensively with in the US (60-70%) and internationally

·          Excellent problem solving skills