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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.

Responsibilities

Ensures 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 assigned clinical studies.
Prepares 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.
Creates study timelines in accordance with corporate goals under the direction of the CTM.
Helps with recruitment efforts.
Participates in internally run studies including updating monitoring plans, documenting on-site monitoring guidelines, forms, and tools.
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.
Expedites study start-up processes for trials and resolves quality issues with documents.
Pre-populates essential document templates and creates essential document packets.
Coordinates site essential document collection for assigned studies and maintains 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.
Provides clinical document and IRB/IEC status updates to the ClinOps team during team meetings.
Develops Consent Documents (CDs) and reviews site CDs following regulatory requirements and NBI SOPs.
Manages the 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 ensures eTMF QC is documented.
Ensures eTMF QC is performed according to the schedule outlined in the TMF Plan, if available.
Performs other duties as assigned.

Requirements

BS/BA in a Scientific field or equivalent AND 2+ years of clinical trials or operations experience.
Master's degree in a Scientific field or equivalent AND some experience.
Working knowledge of clinical drug development process.
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 the Clinical Research industry and its relevant operating environments.
Ability to plan activities and work well under changing circumstances.
Ability to manage time effectively.
Some knowledge of best practices in the functional discipline and familiarity with broader underlying concepts of related business disciplines.
Works to improve tools and processes within the functional area.
Ability to work as part of a team.
Ability to meet multiple deadlines across a project/program with a high degree of accuracy and efficiency.
Developing project management skills.
Ability to analyze data and information to derive options/recommendations for management considerations.

Skills

CRO/Vendor Management exposure is preferred.
Participation in monitoring clinical trials or related experience preferred.
Strong computer skills.
Good communications skills.
Problem-solving skills.
Analytical thinking skills.

Location

Domestic
Global

Work Type

Full-time

Experience Level

2+ years of clinical trials or operations experience
Some experience

Education Level

BS/BA in Scientific field or equivalent
Master's degree in Scientific field or equivalent

About the Company

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs.
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 its 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)

Equal Opportunity

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.