Associate Specialist, Clinical Trials Operations jobs in United States
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Neurocrine Biosciences · 1 day ago

Associate Specialist, Clinical Trials Operations

Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to developing life-changing treatments for patients with neurological disorders. The Associate Specialist in Clinical Trials Operations will support centralized operational activities for clinical studies, ensuring compliance with regulatory standards and assisting with various administrative tasks related to clinical trials.

BiotechnologyHealth CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

Clinical Trials ManagementGCP KnowledgeFDA RegulationsCTMS/EDC/IWRS ExperienceClinical Drug DevelopmentAnalytical ThinkingPlanningOrganizationProblem-SolvingTeam Collaboration

Required

BS/BA degree
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

Preferred

CTMS/EDC/IWRS experience preferred

Benefits

Annual bonus with a target of 15% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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

Company

Neurocrine Biosciences

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Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.

H1B Sponsorship

Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)

Funding

Current Stage
Public Company
Total Funding
$260M
Key Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO

Leadership Team

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Matt Abernethy
Chief Financial Officer
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Dimitri Grigoriadis
VP, Research
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Company data provided by crunchbase