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Sr. Clinical Research Associate

Ionis Pharmaceuticals


Location:
Carlsbad, California
Date:
07/27/2017
2017-07-272017-08-26
Job Status:
Full Time
Categories:
  • Clinical Operations
Ionis Pharmaceuticals
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Job Details

Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.

Sr. Clinical Research Associate

The Sr. Clinical Research Associate is responsible for providing support for one or more clinical trials of higher complexity from trial start-up, conduct, and close-out activities. 

RESPONSIBILITIES:

  • Performs job duties with minimal supervision
  • Communicates with sites regarding trial start-up, conduct, and close-out activities
  • Collects and reviews essential documents from clinical sites
  • Initiates, maintains, and reconciles Trial/Site Master Files
  • Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
  • Organizes and maintains tracking systems and tools to support the conduct of a clinical trial from start-up to close-out
  • Maintains accurate tracking and reporting of study metrics
  • Coordinates communication of tracking information between Ionis Clinical Operations and vendors
  • Assists with the tracking and management of study specific budgets
  • Manages and tracks non-study drug supplies
  • Works with team members from other functional areas (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to prepare trial-related materials/documents.  This includes but is not limited to:
    • Pre-Study Visit Materials
    • Site Initiation materials, Packets and Reference Manuals
    • Trial Master Files
    • Investigator Meeting materials
    • Case Report Forms (CRFs)
    • Clinical Research Agreements (CRAs)
    • Confidential Disclosure Agreements (CDAs)
    • Newsletters
    • Closeout packets
  • Generates, reviews and distributes management reports from internal tracking systems
  • Coordinates investigator meeting planning, including preparing meeting materials and on-site meeting implementation
  • Presents at team meetings as needed (i.e., Project Team Meeting, Investigator Meeting, project training, etc.)
  • Collaborates with Clinical Trial Manager on the development of study-specific plans and/or processes
  • Supports Clinical Operations contract employees
  • Generates meeting agenda and minutes
  • Provides support and mentoring to other Clinical Trial Coordinators as needed
  • Participates in Clinical Operations initiatives and programs as assigned
  • May perform CTM duties under the direct supervision of a senior team member
  • Conducts co-monitoring visits as needed

QUALIFICATIONS:

COMPETENCIES IDENTIFIED FOR SUCCESS

  • Effective written and verbal communication skills
  • Critically evaluates job tasks and the impact on overall trial management objectives
  • Sound problem-solving capabilities
  • Good judgment in triaging issues from internal and external customers
  • Effectively collaborates with Clinical Trial Team members
  • Outstanding organizational skills with the ability to multi-task and prioritize
  • Exceptional attention to detail

EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS

  • Bachelor’s Degree preferred
  • Minimum of four years in clinical research or healthcare related industry, or equivalent combination of education and experience
  • Advanced knowledge of GCP, ICH and FDA guidelines
  • Proficient computer skills in Word, Excel, PowerPoint, and Project
  • Travel may be required

Excellent salary and benefits package offered.

For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #15-0132

 

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