Posted to MedZilla on 4/22/2018


Takeda Pharmaceuticals

US-MA, Clinical Research Associate (CRA) R0001024-MZ


 
 

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Job Description

POSITION OBJECTIVES:

  • Manages the operational components of investigator initiated sponsored research (IISR), including the review, approval, maintenance and close-out processes.

POSITION OBJECTIVES:

  • Works closely with field staff, local representatives, principal investigators and his/her staff to ensure appropriate submissions of all required study documents
  • Ensures communication and information sharing occurs between cross functional groups and study sites as appropriate
  • May contribute to preparation for, or participate in internal review and governance committees for IISR concepts and protocols and Study Progress Review Meetings
  • Coordinates with investigator/site for study updates and receipt of publications/study report
  • Obtains Confidentiality Agreements
  • Assists with performing and/or follows up to gain additional information for Fair Market Value Assessments
  • Manages the operational components of investigator initiated sponsored research (IISR), including the review, approval, maintenance and close-out processes.
  • Budget review, payment schedule, and budget reconciliation at study closure
  • Assist with study drug management and shipments
  • Submits and maintains milestones in the IISR system
  • Contributes to creation of study drug and budget projections
  • Provides training to internal cross-functional colleagues

EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BS degree with 3+ years of progressive experience in Medical Affairs and/or Clinical Operations
  • Thorough understanding of FDA, ICH and GCP guidelines as well as an understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, regulatory affairs, legal, clinical supply, corporate communications, medical affairs and commercial
  • Excellent interpersonal and negotiation skills
  • Strong verbal and written communication skills
  • Proven problem solving and decision making skills
  • Ability to work in a team environment and independently

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

Learn more at takedajobs.com

No Phone Calls or Recruiters Please.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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