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Role Description

Supports multiple complex clinical research studies, which may involve multi-centered, cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies.

• Plans, develops and prepares all required regulatory documents, including all initial, amendments and continuing reviews to the IRB, FDA, Office for Human Resource Protections (OHRP), and other regulatory bodies.
• Supports submissions to ancillary committees.
• Interfaces with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions and ensure timely review and approval in compliance with local and external IRB SOPs and other regulatory agency requirements.
• Collaborates with the Research Business Services Office to assist with initial study submission, amendments and closeout.
• Collaborates with study team to ensure implementation of amendments, awareness of safety and protocol changes, and version control management.
• Acts as a liaison to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events.
• Maintains study level documentation for all studies, including those that are complex in nature. Ensure files are audit ready. Monitors compliance required documentation.
• Enters and maintains study information and regulatory approvals in electronic systems.
• Provides guidance and training to research staff to ensure compliance with highly complex, highly specialized regulations and guidance associated with clinical research studies and trials involving human subjects.
• Attends and participates in educational programs, meetings and assigned committees.
• Participates in the development and implementation of quality improvement and quality assurance activities.
• Other duties as assigned.

Qualifications

• Bachelor's Degree (or equivalent knowledge) in Business or related field.
• Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field.

Requirements

• Typically requires 3 years of experience in research, clinical trials research and regulatory knowledge.
• Knowledge of FDA and DHHS regulations and ICH GCP guidelines, Human Subject Protection rules and regulations related to regulatory documents.
• Knowledge of policies, procedures and SOPs specifically related to regulatory documents.
• Knowledge of clinical trials and terminology required.
• Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines.
• Ability to problem solve and work independently with a high degree of accuracy and attention to detail.
• Good understanding of computer software, Microsoft Office, Word, Excel, Adobe, and Teams.
• Ability to travel between facilities as needed.

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.