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Research Associate - Study Monitor

応募 後で応募 求人ID R0010054 掲載日 07/02/2019 Location:San Diego, California

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Research Associate - Study Monitor in our San Diego office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Futureto people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Research Associate - Study Monitor, you will be empowered to Coordinate regulated (GLP) and Non-GLP nonclinical development and perform and document CRO site visits. A typical day will include:

OBJECTIVE:

  • Coordinate regulated (GLP) and Non-GLP nonclinical development studies at Contract Research Organizations (CROs)
  • Review study-related documents (protocols, amendments, reports, etc.) for completeness, accuracy and consistency
  • Perform and document CRO site visits to monitor study performance
  • Collaborate with multiple departments (Pharmaceutical Sciences, DMPK, QA, etc.) across Global-Takeda for scheduling of study activities

ACCOUNTABILITIES:

  • Coordinate protocol review and dose selection meetings, both internally and externally
  • Coordinate compound and sample shipments between laboratories
  • Establish, schedule, and track study timelines and milestones such as peer reviews and corresponding reports from internal and external laboratories
  • Track reporting deliverables and graph real-time data
  • Maintain study correspondence for assigned studies
  • Ensure finalization of study reports to support regulatory submissions

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  

  • BS in a scientific discipline (or equivalent) with 4+ years of experience, or MS in a scientific discipline with 1+ years of experience working at a pharmaceutical company and/or CRO
  • Candidate should be a self-starter and able to work with minimal supervision to achieve objectives in a timely manner
  • Good working knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, OECD, and ICH guidelines
  • Experience with the design and conduct of regulated nonclinical studies
  • Experience reviewing study data and reports
  • Excellent communication skills and able to effectively communicate both internally and externally in performing role as liaison between Takeda and CRO
  • Strong interpersonal and organizational skills
  • Proficiency with Microsoft Word, Microsoft Excel, and other common electronic systems
  • CRO and laboratory animal experience desired
  • Ability to travel domestically and internationally, 30%

LICENSES/CERTIFICATIONS:

  • AALAS certification desirable

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

    Empowering Our People to Shine

    Discover more at takedajobs.com

    No Phone Calls or Recruiters Please.

    #LI-JT1

Locations

San Diego, CA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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