Associate Specialist, Clinical Trials

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.

What We Do:

Neurocrine Biosciences is 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, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:
Supports the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies. Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start up through closeout for assigned trials. Collaborates with clinical research colleagues within Neurocrine, at Contract Research Organizations (CROs), and at Investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP) and ensuring accurate data, subject safety and impeccable documentation.

Your Contributions (include, but are not limited to):

• 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)
• Prepares and distributes Regulatory Binders, Study Reference Manuals and other study supplies to sites or works with CRO to review and ensure completion
• Assists with/Distributes Safety Reports to all sites, and internal NBI staff as applicable
• Assists with processing vendor invoices
• Establishes collaborative relationships with colleagues in Clinical Development, Regulatory Affairs, Data Management and throughout the Company
• Under the supervision of Clinical Trial Managers (CTMs), helps ensure 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
• Serves as a team member of assigned clinical studies
• Assist in the preparation of data / information for technical and study design discussions
• Provides administrative support, ensuring invoices are paid, tracking metrics, issues for CROs and other contract service providers (CSPs) for assigned studies
• Participates in study team meetings and tracks study issues. Under direction of the CTM, monitors study timelines in accordance with corporate goals. Helps with recruitment efforts
• May participate in internally run studies, including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in onsite monitoring and co-monitoring visits, as necessary.
• Works collaboratively within clinical operations in documenting NBI standard processes across clinical programs
• Develops relationships with investigator sites, IRBs/IECs, and CROs to ensure trial needs and requirements are met
• Collaborates with CTM and fellow team members to expedite study start up processes for trials and to resolve quality issues with documents
• Pre-populates essential document templates and creates essential document packets, or works with CRO to review and ensure completion
• Coordinates site essential document collection for assigned studies and maintain complete and accurate essential documents for the duration of the study, or works with CRO to review and ensure completion
• Assist in preparing IRB/IEC study level submissions and manages site submissions to ensure IRB/IEC compliance throughout assigned trials, or works with CRO to review and ensure completion
• Help create Consent Documents (CDs), and reviews site CDs following regulatory requirements and NBI SOPs
• Manages document translation process with vendors, or works with CRO to review and ensure completion
• Manages distribution of Dear Investigator Letters to clinical sites, IRBs/IECs, and CROs, as applicable
• Supports study monitors by providing updates regarding outstanding documents and addressing eTMF or IRB/IEC related questions
• Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards. Performs sponsor oversight eTMF QC or Inspection Readiness QC within the eTMF system. Works with the NBI and/or the CRO study team to resolve eTMF QC findings and ensure the eTMF QC is documented.
• Ensures eTMF QC is performed according to the schedule outlined in the TMF Plan, if available
• Additional job duties as assigned

Requirements:

• BS/BA degree and some relevant experience - CTMS/EDC/IWRS experience preferred
• Some knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
• Some knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out.
• Some trial management protocol and process knowledge
• General understanding of Clinical Research industry and the relevant environments in which it operates
• Clinical terminology and GCPs knowledge
• 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
• Ability to work as part of a team
• Good computer skills
• Developing communications, problem-solving, analytical thinking, planning and organization skills

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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.