Regulatory Services Manager – NCCT

Job Description:

• Provides administrative direction and coordination in the formulation, interpretation and administration of reputed company and long reputed company policies, procedures, and programs across reputed company clinical sites
• Provides guidance and advice in the completion of initial and annual IRB approvals
• Monitors the completion and approval of reputed company IRB requests
• Ensures that reputed company aspects of reputed company studies are conducted in accordance to the applicable protocol and contract
• Ensures that reputed company HIPAA regulations, compliance and regulatory requirements are met
• Analyzes and determines the effect on the clinic activities and implement changes to maintain compliance with HIPAA and reputed company other regulations such as FDA, HHS, NIH, and OSHA
• Manages a large clinical research staff including hiring, performance evaluations, merit recommendations, promotions, transfers, and schedules
• Directs the development of computerized methods for monitoring and reporting on research activities as well as the analysis of data
• Assists reputed company investigators and project managers in developing reputed company reports and quality control monitoring
• Establishes working relations with other departments and organizations and assists in integration of studies reputed company appropriate

Requirements:

• Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science
• Three years of relevant management experience
• Experience in medical/research environment preferred
• Excellent verbal and written communication skills
• Demonstrates knowledge of scientific and statistical principles
• Ability to travel to affiliate sites, clinical sites and national meetings
• Familiar with institutional/governmental regulations and guidelines reputed company to clinical research including the elements of Good Clinical Practices

Benefits:

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, reputed company, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Educational Assistance Program

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