Clinical Research

Southern Endocrinology Associates PA in Mesquite TX is looking for an experienced person to fill the role of Clinical Research / Study Coordinator. This position will be implementing research studies related Diabetes at our Endocrinology Group Practice.

Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

• Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians.
• Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
• Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s)
• Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.
• Completes case report forms. Extracts data from patient charts in a timely manner
• Responds to data clarification requests in a timely manner.
• May attend Investigator meetings requiring travel and report pertinent information back to research team members.
• Coordinates with PIs and research team to help ensure that clinical research and related activities are performed in accordance with Federal regulations (IRB), Southern Endocrinology and sponsoring agency policies and procedures.
• Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors.
• Performs specimen processing and shipment of biological specimen duties.
• Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
• May perform other job related duties as requested or required

Clinical Research : 1-2 years

Job Type: Full-time