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Company Name: CR Bard
Job Title: CRA Manager
Location: Murray Hill, NJ
Profession: Clinical Development Professionals

Job Description:

Summary of Position with General Responsibilities:
The CRA Manager is responsible for the quality of Clinical Trial Monitoring activities at CR Bard, as manager of Bard internal CRAs and liaison to external CRAs. He / she is involved with the direct management of contract Clinical Research Associates with respect to clinical trial operations. The primary objective and purpose of this position is to ensure the overall quality of clinical trials and integrity of data by developing procedures and monitoring plans and closely supervising CRAs to ensure investigator adherence to the protocol, essential document collection and clean data is obtained. The CRA Manager is the point-person for questions from the project team as well as the liaison that fields questions and uncovers issues reported from external CRAs.
Essential Job Functions:
  • Manage the quality and consistency of outsourced CRA services (via supervision / co-monitoring) across multiple projects; 
  • Provide guidance and mentoring to CRAs to ensure that the studies / activities are conducted in accordance with the protocol, SOPs, GCP and all applicable regulations;
  • Develop Monitoring guidelines and monitoring strategy for sites; reviews all monitoring plans
  • Participate in the development of protocols, CRF, CRF completion guidelines, ICF templates and other study documents;
  • Develop and review reference manuals and regulatory binders created by external service providers;
  • Conduct / oversee training of CRAs regarding study initiation, interim monitoring and study closure and therapeutic area training. train and co-monitor with new clinical monitors;
  • Conducts / participates in meetings with CROs, CRAs, clinical project teams as needed; Assists with organizing and presenting at Investigator Meetings
  • Maintaining trip report tracker and ensuring CRAs are completing reports within appropriate timeframe; Review trip reports as trips are conducted. Provide feedback to CRAs to help to finalize reports.
  • Ensure CRA adherence to SOPs and all Bard practices, policies and procedures; work with Project Managers to address system central and site audit findings;
  • Maintaining/updating weekly status reports for regulatory doc collection, patient enrollment, etc.
  • Provide "back-up" monitoring support when needed. May assist with general on-site monitoring responsibilities;
  • Review and approve CRA expense reports
Basic Qualifications:
• A BS / BA or higher in a related scientific area is required
• Minimum of 5 years related device / pharmaceutical field monitoring
• Management experience
• Thorough understanding of operational aspects of clinical research and regulatory requirements
• Multi-task in fast paced environment
• Ability to work with minimal supervision
• Excellent verbal and written communication skills. Ability to discuss strategic and sensitive issues.
• Demonstrated leadership abilities, problem solving at strategic and operational level, working with others to reach a resolution
Additional Desirable Qualifications Skills and Knowledge:
  • A clinical degree such as RN is preferred
Education and/or Experience:
  •  A BS / BA or higher in a related scientific area is required
  • Minimum of 5 years related device / pharmaceutical field monitoring
  • Management experience
  • Thorough understanding of operational aspects of clinical research and regulatory requirements
  • Multi-task in fast paced environment
  • Ability to work with minimal supervision
  • Excellent verbal and written communication skills. Ability to discuss strategic and sensitive issues.
  • Demonstrated leadership abilities, problem solving at strategic and operational level, working with others to reach a resolution 
Physical Demands:
  • This position will be traveling 30% of the time
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