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. This person may be assigned to one or more locations. Additional travel to other sites as needed for coverage.
While under 60-90% daily oversight of the Director/Assistant Director of Site Operations, the Clinical Research Coordinator (CRC) I is responsible for conducting and managing phase II-IV clinical trials while assuring protocol compliance. This position is also responsible for, but not limited to, overseeing the following: ensuring proper clinical trial protocol is completed at all times to obtain the correct data, collecting patient vitals during each visit, collecting data from pump/meters, working with providers to schedule updated patient checkup, keeping patient binders organized at all times, and communicating with sponsors with updates on patient data. The CRC I is also responsible for preparing written informed consent documents once the trial has been completed.
Key duties include but are not limited to:
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Manages clinical trials from start up to close out. Number of trials may vary depending on nature of study.
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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.
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Responsible for completion of all study documentation forms, including case report forms and other study specific documents.
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Assist Clinical Trial Recruiters/Assistant Clinical Research Coordinators (ACRCs) with recruitment and retention plans for assigned trials.
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Coordinates and conducts patient care visits, including but not limited to: drawing blood, collecting vital signs, performing EKGs, and processing specimens. Assures all procedures are conducted in compliance with the clinical protocol. Processes or ensures proper shipment of lab work.
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Reviews patient journal entries during visitation and documents changes during appointment.
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Interacts with Director/Assistant Director of Site Operations as needed to ensure patient receives appropriate medical evaluation and care when needed.
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Interacts with and maintains close communication with the sponsors Clinical Research Associate.
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Reports serious adverse events and completes reporting to Director/Assistant Director of Site Operations and Principal Investigator.
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Partners with providers to coordinate checkup and documents patient updates post visitation.
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Monitors patient vitals and journal entry trends.
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Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols.
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Oversees sponsor database clean-up process. Ensures accurate reporting of trial data to Principal Investigator.
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Trains patients on how to use pump/incline meter and potential side effects of drugs if applicable.
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Upkeeps all regulator documentation including patient binders.
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Issues payment to patients at the end of the visit.
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Other duties as assigned.
Education & Experience Requirements:
Minimum Required:
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Prior experience as a Clinical Research Coordinator or similar role in a medical setting
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CCRC Certification required after qualifying hours met per the ACRP
Preferred:
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At least 2 years of prior experience as a Clinical Research Coordinator or similar role in a medical setting. Experience in Diabetes and/or Endocrine a strong plus
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Prior experience in a patient care role such as MA, LVN, or RN
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CPR/AED Certification
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CCRC Certification a strong plus
This position will require CCRC certification after meeting all Association of Clinical Research Professional (ACRP) CCRC hours.
AAP/EEO Statement
Texas Diabetes & Endocrinology, P.A. (TDE) provides equal employment opportunities (EEO) to all employees and applicants for employment in accordance with applicable federal, state, and local laws. TDE complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.