Associate Specialist, Clinical Trials Operations

Neurocrine Biosciences

2d

About The Position

Supports and assists the centralized operational activities for assigned Clinical Studies. Centralized activities can include but are not limited to set up of studies, development of Informed Consent documents and study plans, handling IRB submissions of protocol/ICF/sites, management of the Trial Master File (TMF) and Financial Disclosure Forms, feasibility and selection of sites, coordination of committees (i.e. adjudication committees), support of site enrollment, and oversight of monitoring for studies outsourced to Contract Research Organizations (CROs). _ Your Contributions (include, but are not limited to): Assists to ensure that centralized activities for clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies. Works collaboratively with assigned study teams in developing, implementing and ensuring NBI standard processes across clinical programs. Assists with administrative support in the development of processes, tools, templates, and applicable training related to centralized activities and/or monitoring oversight. Supports generating metrics and reports to provide insights into cycle time for centralized activities and/or oversight of outsourced monitoring activities. Works collaboratively within clinical operations in documenting NBI standard processes across clinical programs. Supports inspection readiness activities. Other duties as assigned.

Requirements

• BS/BA degree AND some relevant experience
• CTMS/EDC/IWRS experience preferred
• Some knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out.
• Some trial management protocol and process knowledge
• Good computer skills
• Developing communications, problem-solving, analytical thinking, planning and organization skills
• Ability to work as part of a team
• Some clinical terminology and GCPs knowledge
• Some knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
• Basic knowledge and understanding of applicable regulatory requirements
• General understanding of Clinical Research industry and the relevant environments in which it operates
• Works to improve tools and processes within functional area
• Ability to plan activities and works well under changing circumstances; manages time effectively

Responsibilities

• Assists to ensure that centralized activities for clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies.
• Works collaboratively with assigned study teams in developing, implementing and ensuring NBI standard processes across clinical programs.
• Assists with administrative support in the development of processes, tools, templates, and applicable training related to centralized activities and/or monitoring oversight.
• Supports generating metrics and reports to provide insights into cycle time for centralized activities and/or oversight of outsourced monitoring activities.
• Works collaboratively within clinical operations in documenting NBI standard processes across clinical programs.
• Supports inspection readiness activities.
• Other duties as assigned.

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees