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Assistant Clinical Research Coordinator

Job Summary

The Assistant Clinical Research Coordinator works directly with the Clinical Trial Director (CTD), Clinical Trial Manager (CTM), or the Clinical Research Coordinator (CRC) as a back-up and secondary point of contact for project/protocols.

Essential Job Functions

  • Assists CTD, CTM, or CRC to maintain a cohesive relationship with assigned Client/Sponsor to generate customer satisfaction and continued work.
  • Provide administrative and clinical support related to the collection of clinical data and/or the coordination of project/protocols.
  • Utilize operational experience to assist with start-up and conduct of project/protocol.
  • Assists to coordinate closely with external and internal customers to ensure project/trial conduct excellence from study award to study close-out.
  • Assists to provide key input into Risk Management and Mitigation for assigned project/protocol.
  • Ensure that the operational objectives for projects assigned are met in conformance to all relevant laws, regulations, guidelines, protocols, and internal SOPs/policies
  • Assists to collaborate with internal customers where necessary to support milestone achievement and assists to manage study issues and obstacles.
  • Assists to deliver consistency of operational performance across Client/Sponsor projects/programs.
  • Assists to identify, communicate, attend strategic lessons learned and best practices to promote continuous improvement.

Qualifications

Education

Bachelor’s degree in life sciences or related field and 2 years Clinical Research experience or equivalent combination of education, training and/or experience.

Experience/Training

  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), Good Documentation Practice (GDP/ALCOA), and 21 CFR
  • Excellent customer service and organizational skills
  • Quality minded
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