The business problem is to advance medical care and understanding of rare pediatric diseases by conducting research, including clinical drug trials and longitudinal database studies. The role aims to ensure the smooth and supported journey of patients and caregivers through these trials.
Requirements
- Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements).
- Clinical Research
- Clinical Research Operations
- Clinical Study Protocols
- Computer Systems
- Detail-Oriented
- Organizing
Responsibilities
- Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; 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 funding or sponsoring agency.
- Recruits and enrolls study participants; makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews; develops informed consent packets for study participants and confers with participants to explain purpose of study and obtain completed informed consent packets; explains diagnostic procedures and treatment plans to address participant/family concerns; administers/scores tests and/or evaluates all lab and clinical assessments to ensure they are completed in a timely manner.
- Ensures timely completion of all protocol requirements (assessment, lab testing, procedures and treatments), to include scheduling and facilitating the patient’s timely completion of protocol requirements; evaluates and interprets collected clinical data as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
- Collects clinical data under clinical research protocols.
- Performs other duties as assigned.
Other
- Engaging closely with patients and their caregivers, ensuring their journey through clinical trials is smooth and supported.
- Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
- Communication
- Interpersonal Communication
- Research Support
