Associate Specialist, Clinical Trials

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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 , Facebook and YouTube . ( *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