Neurology - Clinical Research Coordinator | |||||
Location: Coral Gables, FL Employment Type: Full Time Date Posted: 05/24/2022 Expire Date: 07/24/2022 Job Categories: Education |
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Job Description | |||||
Neurology - Clinical Research Coordinator Description: The Department of Neurology has an exciting opportunity for a full-time Clinical Research Coordinator to work in Boca Raton, Fl. The Clinical Research Coordinator provides professional level support for research clinical studies involving human subjects and assists in the design of studies, generation of databases, and update and maintenance of documentation. Moreover, the Clinical Research Coordinator TP develops, verifies, and implements procedures to accomplish research goals. Coordinates routine activities of clinical studies including data maintenance, grant expenditure adherence, project evaluation, meeting scheduling, and research subject interfacing. Tracks medical reports and reviews regulatory documents to generate reports. Serves as project liaison to other departments, outside organizations, government agencies, and product representatives. Recruits patients into the study and reviews on a weekly basis the percentage recruited. Reviews data collected and inserts into the study dataset. Compares the data collected to the monitored phone calls for data quality assurance. Evaluates and monitors timelines for studies and for each subject participant to comply with applicable protocols. Prepares materials for the brochures and retaining letters and mails to appropriate members according to their time in the study. Administers informed consent forms for patients on drug studies. Maintains pool of study candidates and ensures their availability. Coordinates the necessary testing for patient evaluations per physicians’ orders and study protocol requirements. Adheres to University and unit-level policies and procedures and safeguards University assets. Assist the PI in developing UM protocols for submission to IRB, including but not limited to the submission of required documentation to the UM/JMH IRB to ensure successful approval of research protocols. Develop, review and submit required documentation to the UM/JMH IRB to ensure successful approval of research protocols. Maintain any reports and other requirements by the IRB. Interact with various sponsoring agencies and their representatives, on issues regarding on-going protocols requiring occasional visits to supporting agencies and national meetings. Relate information back to the Division. Coordinate patient recruitment and screening procedures in inpatient and outpatient settings. Obtain necessary medical records, schedule patients for pre-study screening, and maintain a study patient list. Coordinate research related activities between departments to accomplish goals of studies Develop and manage the following procedures as they pertain to research studies and patients: Complete patient data forms; collect results from outside laboratories, etc. and complete data into case report forms. Coordinate the necessary testing for patient evaluations per physician’s orders and study protocol requirements. Process and ship lab specimens to central lab as required by protocol and maintain updated study kits and supplies and maintain general laboratory supplies. Assist in keeping accurate records of concomitant medications and study medications as per study protocol requirements. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. MINIMUM QUALIFICATIONS Bachelor’s Degree in the health care field or other related field is desired. Three years (3) work related experience in Clinical Research ideally within the field of neurology/neuroscience), with patient interaction/evaluation. Experience and with the regulatory aspects of clinical research is highly desired. Ability to work independently and collaborate with a team. Excellent verbal and written communication skills are a must. Skill in completing assignments accurately and with attention to detail. Ability to analyze, organize and prioritize work under pressure while meeting deadlines. Ability to process and handle confidential information with discretion. Ability to work evenings, nights, and weekends as necessary. Ability to work independently and/or in a collaborative environment. Contact Information
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