Clinical Trials Assistant- San Diego Based (Hybrid)

Who We Are
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.
What We Do
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. *in collaboration with AbbVie
About The Role
Under general guidance, supports the Clinical team responsible for management of multiple clinical trials (all phases), and assures compliance with Good Clinical Practices (GCPs) and International Conference on Harmonization (ICH) guidelines.
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Your Contributions (include, But Are Not Limited To)

• Provides clerical and administrative support for project team (e.g., assembles and ships study binders, sends mass communications, manages database users in EDC & IWRS, and reviews vendor reports)
• Creates and maintain Study Status Documents (e.g., contact lists, enrollment, CRA Travel Schedule, CRA Site Assignments and Visit Reports)
• Performs other duties as assigned
• Schedules and sets up study team and vendor meetings
• Assists with/Distributes Safety Reports to all sites, and internal NBI staff
• Establishes collaborative relationships with colleagues in Clinical Development, Regulatory Affairs, Data Management and throughout the Company
• Assists with processing vendor invoices
• Prepares and distributes Regulatory Binders, Study Reference Manuals and other study supplies to sites
• Assists study teams with all aspects of the clinical trial (from start-up to closeout) for assigned studies

Requirements

• Completion of Clinical Research Certificate is a plus
• BA/BS in biological or physical life science or a nursing degree preferred and Some experience as noted above
• Applies understanding of company policies and procedures to complete assigned tasks
• Uses established skills to perform a range of daily operations
• Excellent computer skills required (particularly in the Microsoft Office Suite)
• High School Diploma / Associates degree in biological or physical life science or a nursing preferred and2+ years of clinical department of a biotech/pharmaceutical company or completion of related experience required. CTMS/EDC/IWRS experience preferred OR
• Exercise tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness
• Clinical terminology and GCPs knowledge
• Basic knowledge and understanding of applicable regulatory requirements
• Basic knowledge and understanding of CRO clinical systems and procedures
• Good interpersonal, written and oral communication skills to interact with a variety of personalities at multiple levels of the organization
• Able to interact comfortably with company personnel as well as vendors and investigational sites
• Working knowledge of clinical research; regulatory review/submissions; clinical site oversight; protocol review; and use of clinical systems
• Understands how own area contributes to the achievement of objectives
• Must have good organization skills, be a team player, function independently
• Proven ability to multi-task, be proactive and prioritize

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.
We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
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The hourly rate we reasonably expect to pay is $21.85-$34.98. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 15% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.