Clinical Trials Specialist in City of Westminster

Supports the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global). Key contributor to clinical studies using CROs and internally run studies. Manages essential document collection and IRB/IEC submission and approval procedures from start up through closeout for assigned trials. Collaborates with clinical research colleagues within Neurocrine, at CROs, and at Investigator sites to conduct clinical trials adhering to GCP, ensuring accurate data, subject safety and impeccable documentation.

Responsibilities

• Work with the Clinical Trial Managers (CTMs) to ensure clinical studies are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs and policies.
• Serve as a team member for assigned clinical studies.
• Prepare data/information for technical and study design discussions.
• Provide administrative support, ensuring invoices are paid, tracking metrics, and addressing issues for CROs and other CSPs.
• Participate in study team meetings and track study issues; under direction of the CTM, create study timelines and assist with recruitment efforts.
• Participate in internally run studies including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in on-site monitoring and co-monitoring visits.
• Work collaboratively to document NBI standard processes across clinical programs.
• Develop relationships with investigator sites, IRBs/IECs, and CROs to ensure trial needs and requirements are met.
• Collaborate with CTM and team members to expedite study start-up processes and resolve quality issues with documents.
• Pre-populate essential document templates and create essential document packets.
• Coordinate site essential document collection and maintain complete and accurate essential documents for the duration of the study.
• Perform IRB/IEC study-level submissions and manage site submissions to ensure IRB/IEC compliance.
• Provide clinical document and IRB/IEC status updates to the ClinOps team in team meetings.
• Develop Consent Documents (CDs) and review site CDs following regulatory requirements and SOPs.
• Manage document translation with vendors.
• Manage distribution of Dear Investigator Letters to clinical sites, IRBs/IECs, and CROs.
• Support study monitors by providing updates on outstanding documents and addressing eTMF or IRB/IEC questions.
• Ensure eTMF documents are organized and maintained per CRO and NBI SOPs, and conduct sponsor oversight eTMF QC or Inspection Readiness QC.
• Collaborate with NBI and CRO study teams to resolve eTMF QC findings and document QC activities.
• Ensure eTMF QC is performed according to the TMF Plan.
• Other duties as assigned.

Qualifications

• BS/BA in a scientific field or equivalent plus 2+ years of clinical trials or operations experience; CRO/Vendor management experience preferred.
• Master's degree in a scientific field or equivalent plus relevant experience.
• Knowledge of best practices in the functional discipline and related business concepts.
• Ability to work as part of a team; strong computer skills.
• Good communications, problem-solving, analytical thinking skills.
• Ability to meet multiple deadlines with high accuracy and efficiency.
• Developing project management skills.
• Ability to analyze data and provide options/recommendations for management.
• Working knowledge of clinical drug development, ICH, GCP, FDA regulations, and EU Directive.
• Working knowledge of clinical operations from start-up through close-out.
• Some trial management protocol/process knowledge.
• General understanding of Clinical Research and related environments.
• Ability to plan activities and adapt to changing circumstances; time management.