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Principal Clinical Research Associate I (CRA Field Trainer)

Principal Clinical Research Associate I (CRA Field Trainer)

ID 
2017-1322
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Principal CRA I (CRA Field Trainer) will coordinate, implement and deliver CRA training programs in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho's Standard Operating Procedures. This position will be responsible for training Rho's CRAs on industry best practices, evaluating performance while on-site and identifying effective training tools and needs.

Responsibilities

Responsibilities to include but are not limited to:

  • Coordinate and deliver high quality, cost-effective training programs.
  • Identify, select, or develop appropriate training programs, including the selection or design of appropriate training aids.
  • Conduct "training needs analyses" to determine specific training needs for clinical staff.
  • Possible additional responsibility (see below note): deliver in-house training programs for staff preparing to become CRAs.
  • Evaluate effectiveness of training programs and location including cost/benefit analyses.
  • Coordinate and track field visits for established CRAs.
  • Coordinate and track sign-off visits for candidate rising CRAs and newly hired CRAs.
  • Maintain records of training activities and employee progress.
  • Collaborate with the Operational Service Lead for Clinical Operations to research, analyze, and recommend external training programs and areas of focus for training.
  • Assist with revisions to Policy and Procedure documents and/or work process documents.
  • Conduct auditing of work performed by clinical staff and present findings and recommendation for areas of improvement to management.
  • Oversee and manage Clinical Operations Communities of Expertise, including but not limited to:
    • Provide leadership for CoE facilitator group and drive meetings. Act as senior member of facilitator group.
    • Lead CoE meeting pulling in content and feedback from training. CoE should encompass lessons learned, new regulation updates, review of best practices and trainings.
    • Review pain point with documents/templates/procedures at CoE.
    • Provide feedback to A/SLs and OSL on items for follow up as appropriate.

Qualifications

  • Extensive (7-10 years) CRA experience.
  • Experience in conducting on-site monitoring visits.
  • BA/BS, preferably in life science, nursing, or pharmacy field, or its international equivalent from an accredited institution is required.
  • Experience designing and delivering CRA training programs.
  • Superior written and verbal communication skills.
  • Ability to establish and maintain effective working relationships both internally and with clinical site personnel.
  • Required travel is up to 80%. This position is based in Chapell Hill, NC.
  • Demonstrate an understanding of medical/therapeutic area knowledge and medical terminology.
  • Excellent software and computer skills, including MS Office applications is required.

 

EOE.Veterans/Disabled