Assistant II, Clinical Trials

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.

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core 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. For more information, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Assists study teams with all aspects of the clinical trial (from start-up to closeout) for assigned studies

• Creates and maintain Study Status Documents (e.g., contact lists, enrollment, CRA Travel Schedule, CRA Site Assignments and Visit Reports)

• 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)

• Prepares and distributes Regulatory Binders, Study Reference Manuals and other study supplies to sites

• Schedules and sets up study team and vendor meetings

• Assists with/Distributes Safety Reports to all sites, and internal NBI staff

• Assists with processing vendor invoices

• Establishes collaborative relationships with colleagues in Clinical Development, Regulatory Affairs, Data Management and throughout the Company

• Performs other duties as assigned

• High School Diploma / Associates degree in biological or physical life science or a nursing preferred and 2+ years of clinical department of a biotech/pharmaceutical company or completion of related experience required. CTMS/EDC/IWRS experience preferred OR

• BA/BS in biological or physical life science or a nursing degree preferred and some experience as noted above

• Completion of Clinical Research Certificate is a plus

• Able to interact comfortably with company personnel as well as vendors and investigational sites

• Excellent computer skills required (particularly in the Microsoft Office Suite)

• Clinical terminology and GCPs knowledge

• Basic knowledge and understanding of CRO clinical systems and procedures

• Basic knowledge and understanding of applicable regulatory requirements

• Working knowledge of clinical research; regulatory review/submissions; clinical site oversight; protocol review; and use of clinical systems

• Uses established skills to perform a range of daily operations

• Applies understanding of company policies and procedures to complete assigned tasks

• Understands how own area contributes to the achievement of objectives

• Proven ability to multi-task, be proactive and prioritize

• Must have good organization skills, be a team player, function independently

• Good interpersonal, written and oral communication skills to interact with a variety of personalities at multiple levels of the organization

• Exercise tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, 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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