Regulatory Services Manager – NCCT
Job Description:
• Provides administrative direction and coordination in the formulation, interpretation and administration of current and long range policies, procedures, and programs across all clinical sites
• Provides guidance and advice in the completion of initial and annual IRB approvals
• Monitors the completion and approval of all IRB requests
• Ensures that all aspects of all studies are conducted in accordance to the applicable protocol and contract
• Ensures that all 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 all 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 principal investigators and project managers in developing progress reports and quality control monitoring
• Establishes working relations with other departments and organizations and assists in integration of studies when 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 related to clinical research including the elements of Good Clinical Practices
Benefits:
• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, 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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• Provides administrative direction and coordination in the formulation, interpretation and administration of current and long range policies, procedures, and programs across all clinical sites
• Provides guidance and advice in the completion of initial and annual IRB approvals
• Monitors the completion and approval of all IRB requests
• Ensures that all aspects of all studies are conducted in accordance to the applicable protocol and contract
• Ensures that all 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 all 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 principal investigators and project managers in developing progress reports and quality control monitoring
• Establishes working relations with other departments and organizations and assists in integration of studies when 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 related to clinical research including the elements of Good Clinical Practices
Benefits:
• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, 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
Apply tot his job
Apply To this Job