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Temporary Clinical Trial Specialist

Company: Ultragenyx Pharmaceuticals
Location: Novato
Posted on: April 30, 2021

Job Description:

Why Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. During the COVID-19 Outbreak, we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our approach will include video discussions, interviews, and onboarding.Position Summaryultraimpact - Make a difference for those who need it mostThe Clinical Trial Specialist (CTS) is responsible for providing logistical support for one or more clinical trial programs. This position will work closely with cross-functional teams to ensure site start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials.Responsibilities including, but not limited to:* Actively involved in the performance of study feasibility assessments* Develop and review study documents (eg, site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (eg, site specific informed consent forms)* Manage the collection, review and approval of regulatory documents from clinical sites* Coordinate investigational product release activities across clinical sites* Manages and tracks study specific payments* Create study-specific site budgets* Initiate, maintain and reconcile the Trial Master File* Assists in the preparation of Investigator and Study Coordinator Meetings* Set-up and maintain tracking systems (eg, CTMS), tools and report study metrics to support the clinical trial programs* Coordinate communication of tracking information within the study team and to the clinical sites* Develop and review Standard Operating Procedures* Serve as a subject matter expert for the CTS role on initiatives and working groups* Mentor Clinical Trial Associates* May be responsible for the following activities:* Manage ancillary vendors, such as a specialty lab* Assist with study-specific training of Clinical Research Associates* Perform site initiation, routine monitoring and close-out visits at a limited number of clinical sites, as well as co-monitoring with Clinical Research Associates* Review site visit reports, under the direction of the Clinical Program Manager or designee* Negotiate aspects of study-specific site budgetsTechnical Requirements & Skills:* Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)* Previous experience in clinical trial coordination and/or site management* Understanding of study phases and general knowledge of how they apply to clinical development* Working knowledge of ICH Good Clinical Practice guidelines* Able to handle multiple tasks and deadlines* Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors* Able to identify issues and take appropriate actions* Highly effective verbal and written communication skills* Must have the ability to build and maintain positive relationships with management and peers* Experience using computer applications including spreadsheets, email, word-processing software and web-based systems* 10-30% travel may be requiredUltragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: or by emailing us at (see below) For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.See our CCPA Employee and Applicant Privacy Notice.See our Privacy Policy.Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: (see below)

Keywords: Ultragenyx Pharmaceuticals, Novato , Temporary Clinical Trial Specialist, Healthcare , Novato, California

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