Clinical Research Specialist II (Monitoring/Auditing Focus)

While this is a hybrid role, it does require onsite presence for IMVs and audits as needed. For this reason, we can only consider candidates who reside in the local area and are able to come onsite when required

The Clinical Research Specialist II provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities

• Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
• Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
• Coordinates research projects at an institutional or departmental level.
• Communicates project status and improvement areas with leadership in a timely manner.
• Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
• Provides guidance regarding project planning, project logistics, and project implementation.
• May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs

Qualifications

While this is a hybrid role, it does require onsite presence for IMVs and audits as needed. For this reason, we can only consider candidates who reside in the local area and are able to come onsite when required

Required:

• Education: Bachelor’s Degree
• Work Experience: 5+ years of experience in the area of research specialty of monitoring/auditing.