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.
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Your Contributions (include, but are not limited to):Working with the 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 for of assigned clinical studies
Prepares 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, creates study timelines in accordance with corporate goals. Helps with recruitment efforts
Participates 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
Coordinates site essential document collection for assigned studies and maintain complete and accurate essential documents for the duration of the study
Performs IRB/IEC study level submissions and manages site submissions to ensure IRB/IEC compliance throughout assigned trials
Participates in team meetings by providing clinical document and IRB/IEC status updates to the ClinOps team
Develops Consent Documents (CDs), and reviews site CDs following regulatory requirements and NBI SOPs
Manages document translation process with vendors
Manages distribution of Dear Investigator Letters to clinical sites, IRBs/IECs, and CROs
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
Other duties as assigned
BS/BA in Scientific field or equivalent AND 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred. OR
Master's degree in Scientific field or equivalent AND Some experience as noted above
Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
Working 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
Ability to plan activities and works well under changing circumstances; manages time effectively
Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
Works to improve tools and processes within functional area
Ability to work as part of a team
Strong computer skills
Good communications, problem-solving, analytical thinking skills
Sees impact on department
Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency
Developing project management skills
Ability at analyzing data and information to derive options/recommendations for management considerations
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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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