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)
Job Summary:
The Research Coordinator manages protocols to ensure the safety of patients, quality of clinical trial data and compliance with facility, system and Federal Research regulations through oversight of Institutional Review Board (IRB) paperwork, maintenance of all related regulatory document submissions and communication/coordination of study activities with the Primary Investigator and any Sub-Investigators of clinical studies.
Job Requirements:
Bachelor’s degree required. Health-related field preferred.
Research and Data Management experience required.
Certification in clinical research (SoCRA, ACRP) preferred.
Working knowledge of Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, and Access) and a wide variety of software applications.
Proficiency in the review and abstraction of clinical patient information from a medical record.
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