Clinical Research Coordinator I

Texas Diabetes & Endocrinology, P.A. (TD&E) has grown over the years to meet the Endocrinology needs of the Austin community. Our mission is to strive to provide expert care in Diabetes, Thyroid problems, Osteoporosis, Weight management and hormonal conditions by providing thorough evaluations and innovative, personalized solutions focused on our patients success. Our employees are the strength that keeps us moving forward.

Our Clinical Research Department is looking for a Clinical Research Coordinator (CRC) I role at our Far West/Central location!

Purpose: The Clinical Research Coordinator (CRC) is a specialized research professional who works closely with and under the guidance of the Principal Investigator (PI) in clinical research. While the PI is primarily responsible for the overall design, conduct, and management of phase II – IV clinical trials, the CRC plays a key role in supporting, coordinating, and facilitating the day-to-day activities of the study. The CRC ensures the study is conducted in compliance with the protocol, relevant regulations, Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements. In addition to administrative tasks, the CRC may be responsible for serving as a liaison between the clinical site and sponsors, ensuring that the research team is trained according to the protocol, recruiting and/or registering participants, maintaining study protocols, and overseeing data collection and review before it is entered into the study database. Through these activities, the CRC collaborates with the PI, Director of Operations, department, and sponsor to ensure the studies are successful.

Essential Functions:

       Study Coordination:

• Manages complex endocrine-related trials ensuring they adhere to protocols, are ethically conducted, and follow regulatory standards
• Maintains a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and drug accountability requirements
• Liaises with laboratories regarding lab results and/or queries
• Directs the collection, labeling, storage, and transport of all specimens
• Ensures that all equipment and supplies needed for the study are in stock and in good working order
• Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols

Participant Management:

• Responsible for screening potential patients including obtaining HIPAA authorization, informed consent for the study, reviewing medical records to determine eligibility, and communicating with the investigator and patient
• Completes and maintains research records of study activity including source documents, case report forms, drug dispensation records, and other regulatory forms as per FDA guidelines
• Ensures proper clinical trial procedures are performed to obtain the correct data, performs medical procedures, and collects data from pump/meters
• Responsible for investigational product (IP) handling, accountability, reconstitution, and destruction
• Understands serious adverse events and adverse event reporting. Reports accurately.
• Communicates with participants regarding study objectives
• Administers questionnaires and monitors participants to ensure adherence to the study’s rules and completion of questionnaires following Good Documentation Practices (GDP)
• Reviews patient diaries and ensures all data is completed following GDP