Specialist, Clinical Trial Operations

Neurocrine Biosciences • San Diego, CA

2d • $89,800 - $123,000

About The Position

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. Oversees CRO management of essential documents, IRB/IEC submissions, and regulatory documentation to ensure compliance with study timelines, GCP, and applicable regulations. Performs sponsor oversight of critical regulatory deliverables. 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.

Requirements

• 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
• 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

Nice To Haves

• CRO/Vendor Management exposure is preferred.
• Participation in monitoring clinical trials or related experience preferred.

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.
• Collaborates with internal cross-functional teams, CRO partners, vendors, and investigator sites to ensure timely execution of study activities while maintaining subject safety, data integrity, and regulatory compliance.
• 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.
• Reviews CRO-developed monitoring plans and study management documents to ensure alignment with protocol, sponsor expectations, and risk-based monitoring strategies. Supports sponsor oversight activities including co-monitoring visits, when appropriate.
• 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.
• Partners with CTMs and CROs to oversee study startup activities including country activation, regulatory submissions, contract status, and site activation timelines. Identifies and escalates startup risks.
• Reviews sponsor-level essential documents and oversees CRO completion of site regulatory documentation to ensure completeness and compliance.
• Oversees CRO management of essential document collection and ensures sponsor oversight of TMF completeness and inspection readiness.
• Oversees CRO management of IRB/IEC submissions and regulatory approvals while ensuring compliance with sponsor timelines and applicable regulations.
• Coordinates development and review of informed consent templates and oversees CRO/site implementation to ensure regulatory and sponsor compliance.
• Performs IRB/IEC study level submissions and manages site submissions to ensure IRB/IEC compliance throughout assigned trials.
• Develops Consent Documents (CDs), and reviews site CDs following regulatory requirements and NBI SOPs.
• Coordinates vendor management activities related to translation services and other study support vendors.
• Coordinates sponsor communications to CROs and investigator sites including Dear Investigator Letters, protocol updates, and study communications
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level