Associate Specialist, Clinical Trials

About the Company

Neurocrine Biosciences is a leading biopharmaceutical company 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 of compounds in mid- to late-phase clinical development. For over three decades, Neurocrine has applied unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions. (*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). A 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 close-out for assigned trials.

Responsibilities

• Assists study teams with all aspects of the clinical trial (from start-up to close-out) for assigned studies.
• Creates and maintains 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 FDA regulations, EU Directive, ICH guidelines, and NBI Standard Operating Procedures (SOPs) and policies.
• Serves as a team member of assigned clinical studies.
• Assists in the preparation of data/information for technical and study design discussions.
• Provides administrative support, ensuring invoices are paid, tracking metrics, and issues for CROs and other contract service providers (CSPs) for assigned studies.
• Participates in study team meetings and tracks study issues. Monitors study timelines in accordance with corporate goals under the direction of the CTM.
• 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 on-site 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 maintains complete and accurate essential documents for the duration of the study, or works with CRO to review and ensure completion.
• Assists 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.
• Helps create Consent Documents (CDs) and reviews site CDs following regulatory requirements and NBI SOPs.
• Manages the 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 the 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 the 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.

Pay

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 skills. In 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

• Retirement savings plan (with company match).
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits to include medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.