Clinical Trial Administrator

工作内容

Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.

The Opportunity

The Clinical Trial Administrator(CTA) is responsible for supporting clinical trials with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). The CTA may also provide administrative support for the Zug based Clinical Operations department.

What You Will Dive Into

• Support the Clinical Operations teams with ongoing conduct of European studies
• Be familiar with ICH, GCP, appropriate regulations, relevant Arena SOP’s and internal systems
• Coordination and scheduling of study team meetings, vendor meetings and other large group meetings
• Recording, distributing and filing of study team meeting minutes and materials
• Set up and maintain internal electronic filing systems
• Route study documents to the trial master file according to study requirements; coordinate receipt of final trial master files (TMFs), participate in auditing the TMF based on file specifications and inventory
• Manage and maintain study documents or trackers
• Collection, routing and tracking of clinical trial related documents such as country and site regulatory documents, letters of delegation, informed consent forms (ICFs), etc.
• Review and approval of essential documents to support site activation
• Create and maintain study contact lists for internal/external/sites/vendors
• Coordinate ordering and tracking of clinical trial supplies (e.g. CRFs, diary cards, lab supplies, drug supplies)
• Assist project teams with study specific documentation and guidelines as appropriate
• Facilitate clinical trial insurance documentation and document translations
• Collaborate with CRO, vendors and cross-functional counterparts; correspond with site staff and vendors
• Route contract requests (e.g., confidentiality agreements [CDAs], clinical trial agreements [CTAs])
• Track and process vendor invoices
• Perform other administrative duties as assigned
  

What We Expect

• Relevant work experience or High School Diploma (or equivalent); Bachelor’s degree in science/research-related field, preferred
• 2+ years of experience in clinical trials and familiar with clinical trial methodology and GCP preferred
• Strong written and verbal communication skills and computer literacy (eg, Microsoft Word, Excel, Powerpoint, Outlook)
• Excellent organizational skills with attention to detail
• Ability to manage multiple tasks and follow-up to resolution
• Team player with positive attitude
  

What We Offer

• To be part of a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
• Opportunities to learn and contribute to creative solutions
• Competitive compensation package including long-term incentives
• Comprehensive health insurance (highly subsidized cost sharing on all medical plans)
• Generous matching 401k retirement plan
• Flexible time off policy and holidays including two company-wide shut-down periods each year
• Multi-cultural work environment
• Company celebrations
  

This role is to be filled outside of the state of Colorado.

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us atjobs@arenapharm.com.

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