Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Clinical Research Coordinator IIMedicine - Tulane Research Innovation for Arrhythmia Discoveries
Location: New Orleans, LA
SummaryThe Clinical Research Coordinator II will coordinate and conduct the day-to-day operations of TRIAD ongoing studies in cardiovascular diseases.
The Clinical Research Coordinator II is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations.
As the primary resource for protocols, the Clinical Research Coordinator acts as a liaison between the patient, investigator, Institutional Review Board and sponsor.
The Clinical Research Coordinator II screens, enrolls and follows study patients, ensuring protocol compliance, and effective monitoring of clinical trial subjects.
The Clinical Research Coordinator II is also responsible for all data and source documentation, adverse event reporting and maintenance of complete regulatory files.
*Bachelor's Degree in public health or other science area or RN with current state licensure at the time of hire and one (1) year of related work experienceOR*LPN with current state licensure at the time of hire and four (4) years of related work experience; OR*Master's Degree in a related field
Preferred Qualifications*Knowledge of IRB submission process and requirements.
*Knowledge of good clinical practices as set forth by federal regulations.
About the Company:
Tulane University
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