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CRO Coordinator Early Development
Ref No.: 18-08570
Location: Cambridge, Massachusetts

Job Title: CRO Coordinator Early Development
Job ID: 8238446
Job Location: Cambridge, MA
Job Duration: 6+ Months (Possibility of extension)


Job Description:
  • The Early Development Operations is looking for a 6-month contractor, CRO Study Coordinator to help support the contracting of non-clinical and research studies with our CROs. 
  • CRO Study Coordinators are critical to the success of the Early Development group and are primarily responsible for helping coordinate protocol development, animal orders, test article projections, and shipments. 
  • The Coordinator will work closely with functional area representatives within Early Development and will collaborate with cross-functional project team members. 
  • We are looking for someone that has proven ability to effectively manage multiple projects and timelines simultaneously.

Skills:
  • Interface knowledgeably with related disciplines (and show a willingness to learn) including toxicology, pathology, DMPK, biology, clinical, regulatory, pharmacology.·         
  • Submit Concept Sheets to CROs and obtain competitive bids and timelines and negotiate as appropriate.·              
  • Interface effectively with Business Planning & Program Management and Accounting/Finance departments to assist with investment plan forecasting, award contracts and to review and process CRO invoices for payment.    
  • Assist Research and Early Development personnel in preparation for CRO studies (e.g. protocol development, animal orders, test article projections, and shipments).·           
  • Interface effectively with CMC and Supply Chain to manage test article supplies and orders.·           
  • Interface effectively with CMC Analytical Chemistry to assure GLP-compliant test article characterization and re-tests.·           
  • Serve as Study Monitor for Day 1 dosing and other key study milestones at CROs·    
  • Assist with protocol and amendment generation and circulation.·      
  • Maintain complete, organized, and current study files including study schedules, contracts, protocols, and other applicable documents and correspondence.·         
  • Participate in regular teleconferences with CROs including but not limited to: pre-study meetings, bi-weekly/monthly CRO program meetings, and pre-reporting ( "tox/path ") meetings.·         
  • Interface effectively with technical writing group and other Alnylam personnel to manage/track internal report and sub-report timelines and status.·           
  • Interact cross functionally within the Early Development group, with project teams, as well as across other drug development expertise areas.·           
  • Provide administrative support for contracted non-clinical studies.

Education:
  • B.S. in biology/toxicology or a related field with 0-3 years relevant experience in the biotechnology/pharmaceutical industry or contract research organization.·       
  • Knowledge of national and international GLPs is a plus·      
  • Previous experience in conducting laboratory animal research studies a plus.·  
  • Working knowledge of invoicing/accounting/contract management preferred. ·               
  • Demonstrated organizational and multi-tasking skills and effective time management.·               
  • Outstanding communicator responsible for conveying key messages to internal stakeholders and external vendors. ·         
  • Ability to navigate and be successful in a fast-paced, highly-networked and program team driven environment