Neurocrine Biosciences · 12 hours ago
Specialist, Clinical Trials
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$90K/yr - $123K/yr
2+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to relieving suffering for people with great needs. The Specialist in Clinical Trials will support operational activities for clinical studies, ensuring compliance with regulatory standards and collaborating with various stakeholders to manage essential documents and facilitate trial processes.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Qualification
Required
BS/BA in Scientific field or equivalent AND 2+ years of clinical trials or operations experience
Master's degree in Scientific field or equivalent AND Some experience as noted above
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
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
Preferred
CRO/Vendor Management exposure
Participation in monitoring clinical trials or related experience
Benefits
Annual bonus with a target of 20% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase