Associate Specialist, Clinical Trials

Neurocrine Biosciencesis 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 companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons 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 and follow the company onLinkedInX Facebook and YouTube. (*in collaboration with AbbVie)

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.

• 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

• 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 dont line up to exactly what we have outlined in the job description.

The hourly rate we reasonably expect to pay is $35.35-$47.34. Individual pay decisions depend on various factors such as primary work location complexity and responsibility of role job duties/requirements and relevant experience and 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.