Clinical Trials Regulatory Mgr
Job Title: Clinical Trials Regulatory Mgr
Location: Augusta University
Full/Part Time: Full-Time
Job ID: 228306
Required Qualifications Bachelor's degree from an accredited college or university and 10 years of relevant experience.
Master's degree from an accredited college or university and 7 years of relevant experience.Knowledge, Skills, & Abilities Ability to maintain confidentiality
Ability to use sound judgement and work independently
Excellent interpersonal, written and verbal communication skills
Proficient in Microsoft Office and other computer software/databasesResponsibilities Performs advanced administrative and technical work in support of clinical research trials. Managers several large, multi-center, investigator-initiated, federal, and industry sponsored clinical trials. The duties include, but are not limited to:
- Prepares new clinical research protocols for IRB submission, in compliance with all applicable regulations and policies of FDA, DHHS, ICH, state of Georgia, AU and AUHI. Coordinates activities with respective campus departments to ensure successful study executions.
- Performs regulatory activities associated with the ongoing management of current clinical research protocols, including, but not limited to, protocol amendments, financial disclosure, protocol deviations, protocol departures, adverse events.
- Provides regulatory support to cancer center clinical investigations and clinical staff.
- Acts as a liaison between clinical trial sponsors (or contract research organizations), clinical investigations, and the IRH, and coordinates efforts towards the start-up and ongoing conduction of a clinical trial.
- Performs quality control regulatory inspections of cancer center clinical trials to ensure regulatory compliance.
- Perform all other related duties as assigned.
All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during the course of their employment and beyond.Equal Employment Opportunity Augusta University is proud to be an equal opportunity employer welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.Driver's License Statement The Human Resources Division will request a driver's history report from the selected candidate. This report will come from the Department of Motor Vehicles. The candidate must have a current valid driver’s license. Other Information This position is also responsible for promoting a customer friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner everyday with patients and families for success."
Augusta University is a tobacco free environment and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited.