Manager, Quality Assurance
RemoteMiami, Florida, United States or Florida, United States
EXPIREDMiami, Florida, United States or Florida, United StatesRemoteFull TimeBachelors DegreeEDUCATIONLarge
Full TimeBachelors DegreeLargeEDUCATION
Job Summary
Conduct routine audits of human subject research protocols to ensure compliance with federal, state, and local regulations. Prepare reports of investigations and inquiries for internal or external use, while advising officials of deficiencies and recommending corrective actions. Train and mentor quality assurance auditors, and establish internal policies and standard operating procedures. Monitor new legislation, maintain quality assurance databases, and assist research teams with responses to regulatory agency observations.
Required Qualifications
- Bachelor's Degree in relevant field
- Minimum 5 years relevant experience
- Ability to maintain effective interpersonal relationships
- Ability to communicate effectively in both oral and written form
- Skill in collecting, organizing, and analyzing data
- Ability to recognize, analyze, and solve a variety of problems
- Ability to exercise sound judgment in making critical decisions
- Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates or obtained within 1 year of hire
- High-level interpersonal skills
- Excellent English oral and written communication skills
- Thorough understanding of Good Clinical Practice guidelines and the Code of Federal Regulations
- Proficient with Microsoft Office Suite including Excel and Power Point
- Knowledge of medical terminology
- Ability to manage multiple tasks simultaneously
- Attention to detail & accuracy
Desired Qualifications
- Medical and/or science education
- Oncology and cooperative group clinical trial experience
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.