Clinical Trials Specialist will be supporting Phase I studies while playing a pivotal role in the successful execution of cutting-edge phase I clinical studies at Neurocrine! As a key player in the planning, conduct, and wrap-up of both domestic and global trials, you will be at the forefront of innovation in healthcare. From managing essential documents to ensuring adherence to Good Clinical Practice and maintaining impeccable documentation, you'll be making a meaningful impact on the future of medicine. Collaborate with top-tier professionals both internally and externally and be a driving force in promoting subject safety and data accuracy. Your Contributions (include, but are not limited to): 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. 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; 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.
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