About the Role:
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. Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start up through closeout for assigned trials. 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.

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Your Contributions (include, but are not limited to):

• 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

• 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

• Participates in internally run studies including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in onsite monitoring and co-monitoring visits, as necessary

• 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

• Pre-populates essential document templates and creates essential document packets

• Coordinates site essential document collection for assigned studies and maintain complete and accurate essential documents for the duration of the study

• Performs IRB/IEC study level submissions and manages site submissions to ensure IRB/IEC compliance throughout assigned trials

• Participates in team meetings by providing clinical document and IRB/IEC status updates to the ClinOps team

• Develops Consent Documents (CDs), and reviews site CDs following regulatory requirements and NBI SOPs

• Manages document translation process with vendors

• Manages distribution of Dear Investigator Letters to clinical sites, IRBs/IECs, and CROs

• Supports study monitors by providing updates regarding outstanding documents and addressing eTMF or IRB/IEC related questions

• 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

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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The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.