Clinical Research Associate

Princeton , NJ
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 147315

Date Posted: 11/08/2019


Clinical Research Associate

Location: Princeton, NJ

Direct Hire

Must haves:

  •  
  • At least 2 years experience in a pharmaceutical, bio tech,CRO or Healthcare setting 
  • Experience working with CRO's and outside vendors 
  • OK with 25% domestic travel 

Required Skills:

 

  • Ability to work in a virtual, cross-functional team environment.
  • Knowledgeable of clinicalresearch operations and FDA regulations/ICH/GCP guidelines
  • Ability to work on complex or multiple projects and exercise critical thinking with minimal supervision
  • Excellent verbal and written communication skills
  • Team player; willingness and ability to fill functional gaps
  • Selfmotivated and adaptable to a dynamic environment
  • Willingness to travel (~25%)
  • Comfortable multi-tasking in a fast-paced small company environment

 

Responsibilites:

  •  Acts as primary point of contact for investigative sites and cross functional teams and escalates to the study lead as necessary.
  • Assists in the development of study-related documents such as study manuals,monitoring plans, informed consents, recruitment materials and other study related tools.
  • Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and User Acceptance Testing (UAT).
  • Performs in-house review of clinical data listings for completeness and accuracy and escalate issues as needed.
  • Responsible for the development and distribution of study newsletters and tracking/reporting of recruitment updates.
  • May participate in co-monitoring and/or training visits, TMF and on-site audits as requested.
  • Participates in the training of investigative sites and third-party vendors.
  • Assists with providing oversight of CROs and vendors, including managing crossfunctionalteams.
  • Works to ensure that trials are conducted in adherence to study protocols, applicable SOPs, FDA regulations, ICH/GCP guidelines and local government regulations.
  • Assists with the organization and management of internal meetings, investigator meetings and other trial specific meetings as required.
  • Performs other work-related duties as assigned

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