Jobs
>
London

    Specialist, Clinical Trials - United Kingdom - Neurocrine Biosciences

    Neurocrine Biosciences
    Neurocrine Biosciences United Kingdom

    1 week ago

    Default job background
    Description

    Specialist, Clinical Trials page is loaded

    Specialist, Clinical Trials

    Apply remote type On-Site locations United Kingdom time type Full time posted on Posted 2 Days Ago job requisition id R4357

    Who We Are:

    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, but few options.

    What We Do:

    Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

    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.

    _

    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 OR
    • Master's degree in Scientific field or equivalent
    • 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

    #LI-TM1

    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.

    About Us

    OUR VALUES:

    • PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.
    • INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.
    • COLLABORATION : We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
    • INNOVATION : We seek and create optimal solutions.
    • TENACITY: We do not quit. We adapt. We accomplish what others cannot.

    Come join our team during this exciting time of growth and opportunities

    We are a top place to work.

    Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2023.

    We were also named a Great Place to Work Certified company and were recognized on Great Place to Work's Best Workplaces for Parents 2020 list.

    #J-18808-Ljbffr
  • University College London Hospitals NHS Foundation Trust

    Clinical Trial Assistant

    5 days ago

    University College London Hospitals NHS Foundation Trust London, United Kingdom

    The main role of the clinical trials administrator is to support the CCTU team in the administration and running of the in-house, national and international phase I, II and III clinical trials. Responsibilities include creation and maintenance of files for clinical trials, handli ...

  • Compass Recruitment Solutions

    Clinical Trials Coordinator

    3 days ago

    Compass Recruitment Solutions London, United Kingdom

    Compass Life Sciences are privileged to be partnering with an emerging CRO, specialising in treatment for mental health services. Working with clinical trials such as Migraine, ADHD, Dementia and Brain Injuries, supporting in their search to appoint a ClinicalTrials Coordinator. ...

  • Informa Intelligence

    Clinical Trial Disclosure

    4 days ago

    Informa Intelligence London, United Kingdom

    Company Description · Citeline is one of the world's leading providers of data and intelligence on clinical trials, drug treatments, medical devices and what's new in the regulatory and commercial landscape. Relying on us to deliver vital advantage when making critical R&D and co ...

  • King's College Hospital NHS Foundation Trust

    Clinical Trials Coordinator

    3 days ago

    King's College Hospital NHS Foundation Trust London, United Kingdom

    Treatment for cystic fibrosis has changed significantly over the past 10 years, with more advances in care and therapies than ever before. Clinical trials in cystic fibrosis are the foundation of these new treatments, with many experimental treatments in the pipeline. The Clinica ...

  • Hammersmith Medicines Research

    Clinical Trials Associate

    1 day ago

    Hammersmith Medicines Research London, United Kingdom

    **Clinical Trials Associate and training leading to a** · **University Certificate in Clinical Pharmacology Practice** · North West London · **Starting salary £27,500** with structured 6-monthly reviews · rising to **£30,000 **in **6 months** and **£36,500 **in **2 years** · + es ...

  • Talentspa

    Clinicals Trials Administrator

    4 days ago

    Talentspa London, United Kingdom

    **Clinical Trials Administrator** · **Location**: London · **Hours of Work**:Full time, 40 hours per week · **Salary**:£24,000 - £27,000 per annum · **Employment Type**:Permanent Contract · **About the Company**: · Re: Cognition Health is a leading provider of clinical services s ...

  • King's College London

    Clinical Trials Facilitator

    1 week ago

    King's College London London, United Kingdom

    Job Description · The King's Health Partners Clinical Trials Office (KHP-CTO) is a collaboration between King's College London, Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It is set up ...

  • King's College London

    Clinical Trials Facilitator

    3 days ago

    King's College London London, United Kingdom

    Job id: Salary: £32,979 - £36,396 per annum, including London Weighting Allowance. · Posted: 24 January 2024. Closing date: 06 February 2024. · Business unit: Research Management & Innovation. Department: KHP Clinical Trials Office. · Location: Guy's and Denmark Hill Campuses. Ca ...

  • Re:Cognition Health

    Clinical Trials Administrator

    1 week ago

    Re:Cognition Health London, United Kingdom

    **About the Company**: · Re: Cognition Health is a leading provider of clinical services specializing in cognitive impairment. We deliver expert clinical care to private patients and are one of the foremost providers of clinical trials in the world and deliver award winning medic ...

  • Bank Partners

    Clinical Trial Assistant

    1 week ago

    Bank Partners London, United Kingdom

    **Clinical Trial Assistant - EC1A 7BE** · We have an exciting opportunity for a Band 4 Clinical Trial Assistant to join our team at the St Bartholomew's Hospital, located in West Smithfield, EC1A 7BE. · St Bartholomew's Hospital (Barts), is a leading, internationally renowned tea ...

  • Imperial College London

    Clinical Trial Coordinator

    1 week ago

    Imperial College London Charing Cross, United Kingdom

    **The Imperial jobs site will be temporarily unavailable from 16.00pm Friday 23rd February to 12.00pm Wednesday 28th February as we move to a new Job site platform.** · **Applications started, not yet submitted by 16:00 23rd February will need to be started again on the new platf ...

  • University College London

    Clinical Trials Coordinator

    1 week ago

    University College London London, United Kingdom

    **Ref Number** · B · **Professional Expertise** · Administration and Business Support · **Department** · School of Life & Medical Sciences (B02) · **Location** · London · **Working Pattern** · Full time · **Salary** · £39,508 - £47,355 · **Contract Type** · Permanent · **Working ...

  • University College London Hospitals NHS Foundation Trust

    Clinical Trials Assistant

    5 days ago

    University College London Hospitals NHS Foundation Trust London, United Kingdom

    The main role of the clinical trials administrator is to support the CCTU team in the administration and running of the in-house, national and international phase I, II and III clinical trials. Responsibilities include creation and maintenance of files for clinical trials, handli ...

  • Park Street People

    Clinical Trials Coordinator

    4 days ago

    Park Street People London, United Kingdom

    This is an exciting opportunity for a Clinical Trials Coordinator to join a research organisation based in London. · This is a chance to join research leaders within Neurology. You will use your experience within Clinical Trials and be responsible for the set up and delivery of a ...

  • University College London Hospitals NHS Foundation Trust

    Clinical Trials Assistant

    1 week ago

    University College London Hospitals NHS Foundation Trust London, United Kingdom

    The main role of the clinical trials assistant is to support the CCTU team in the administration and running of the in-house, national and international phase I, II and III clinical trials. Responsibilities include contacting patients by phone, assisting the clinical trial practi ...

  • St. George's University of London

    Clinical Trial Coordinator

    3 days ago

    St. George's University of London London, United Kingdom

    We are looking for an enthusiastic and efficient Clinical Trial Coordinator to join St George's Vaccine Institute, which undertakes a wide range of paediatric and adult research. As Clinical Trial Coordinator you will be responsible for supporting the Clinical Trial Managers, Pro ...

  • St. George's University of London

    Clinical Trial Assistant

    1 week ago

    St. George's University of London London, United Kingdom

    We are looking for an enthusiastic and efficient Clinical Trial Assistant to join the Centre for Neonatal and Paediatric Infection (CNPI). The CNPI undertakes a variety of projects and studies in children focusing on the epidemiology of vaccine-preventable diseases, clinical vacc ...

  • University College London Hospitals NHS Foundation Trust

    Clinical Trials Practitioner

    1 week ago

    University College London Hospitals NHS Foundation Trust London, United Kingdom

    The Research Nurse/Clinical Trial Practitioner is an autonomous specialist working within the multi-disciplinary team. · We are seeking someone with experience of Cancer Nursing or Clinical Research, knowledge of good clinical practice, good verbal and written communication. Howe ...

  • Hammersmith Medicines Research

    Clinical Trials Associate

    1 week ago

    Hammersmith Medicines Research London, United Kingdom

    **Clinical Trials Associate and training leading to a** · **University Certificate in Clinical Pharmacology Practice** · North West London · **Starting salary £27,500** with structured 6-monthly reviews · rising to **£30,000 **in **6 months** and **£36,500 **in **2 years** · + es ...

  • IQVIA

    Clinical Trial Coordinator

    3 days ago

    IQVIA London, United Kingdom

    Join IQVIA on our mission to drive healthcare forward · Our Sponsor Dedicated team are looking for Clinical Trial Coordinators and Senior Clinical Trial Coordinators. · Essential Functions · - Provide clinical research support to investigators to prepare for and execute assigned ...