Implements and manages all phases of clinical research studies, protocols, and related program activities; ensures compliance with protocol guidelines and requirements of regulatory agencies and sponsoring organizations; establishes and maintains appropriate record-keeping systems; monitors participants’ progress and study activities; analyzes, investigates and reports adverse events; makes decisions as to when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with investigators, clinical teams, funding or sponsoring agency, and study participants and families. Recruits and enrolls study participants and/or facilities participation in research and screening activities; makes and/or participates in making determinations of eligibility based on established study criteria and participant information; develops and/or maintains study materials and informed consent documentation, as applicable; communicates with study participants and families regarding study purpose, procedures, screening opportunities, and visit requirements; address routine participant and family questions and facilitates communication with appropriate clinical or research personnel.