Clinical Trial Specialist

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.

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

_

• Work alongside Clinical Trial Managers to ensure compliance with regulatory guidelines and company SOPs

• Serve as a key team member for assigned clinical studies

• Provide administrative support by handling invoices, tracking metrics, and managing issues with contract service providers

• Participate in study team meetings, tracking study issues, and assisting with recruitment efforts

• Collaborate within clinical operations to document standard processes across clinical programs

• Develop relationships with investigator sites, IRBs/IECs, and CROs to meet trial requirements

• Coordinate essential document collection and IRB/IEC submissions, ensuring compliance throughout trials

• Facilitate study start-up processes and resolving quality issues with documents

• Support study monitors with document updates and addressing related questions

• Ensure eTMF documents are organized according to SOPs, policies, and standards

• Perform eTMF QC or Inspection Readiness QC and documenting findings for resolution

• Additional duties as assigned to contribute to the success of clinical trials

• BS/BA in Scientific field or equivalent and 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred OR

• Master's degree in Scientific field or equivalent and some experience as noted above

• 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

• 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

#LI-SA1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, 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.

_