Specialist, Clinical Trials
Not Disclosed•Full-TimeOn-site
location_onBig Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States
Who We Are
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. Our diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids, alongside a robust pipeline of compounds in mid- to late-phase clinical development.
About the Role
This role supports the operational activities for the planning, initiation, conduct, and close-out of assigned clinical studies, both domestic and global. You will be a key contributor to clinical studies utilizing Contract Research Organizations (CROs) and internally run studies. The position involves managing essential document collection and overseeing Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start-up through close-out. You will collaborate with clinical research colleagues within Neurocrine, at CROs, and at investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP), ensuring accurate data, subject safety, and impeccable documentation.
Our Commitment to Diversity
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 exactly to what we have outlined in the job description.
Work location
Work model: On-site
Big Bully Turf, 350, Front Street, Banker's Hill, San Diego, San Diego County, California, 92101, United States
San Diego, California
Similar Job Opportunities
Skills, education and keywords
Skills: Clinical Trials, Clinical Operations, Cro Vendor Management, Ich, Good Clinical Practices, GCP, Fda Regulations, Eu Directive, Clinical Drug Development, Trial Management.
Education: Master's degree in Scientific field or equivalent with some experience.
Frequently asked questions about Specialist, Clinical Trials at Neurocrine Biosciences
What does a Specialist, Clinical Trials at Neurocrine Biosciences do?expand_more
Day-to-day, the Specialist, Clinical Trials at Neurocrine Biosciences will manage essential document collection and irb/iec submission and approval procedures from start-up through closeout; prepare data and information for technical and study design discussions; update monitoring plans, document on-site monitoring guidelines, and participate in onsite monitoring and co-monitoring visits; and develop relationships with investigator sites, irbs/iecs, and cros to ensure trial needs and requirements are met.
What are the requirements for this Specialist, Clinical Trials role?expand_more
Neurocrine Biosciences is looking for candidates who meet the following requirements: BS/BA in Scientific field or equivalent with 2+ years clinical trials experience; Master's degree in Scientific field or equivalent; Working knowledge of ICH, GCP, FDA regulations, and EU Directive; Working knowledge of clinical operations from start-up through close-out; and Strong computer skills.